Sarcopenic Obesity, Aging
Conditions
Brief summary
This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.
Detailed description
A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity. Lifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.
Interventions
DIETARY_SUPPLEMENTProtein supplement
40g of whey protein in the breakfast;
DIETARY_SUPPLEMENTisocaloric supplement
42g of isocaloric supplement in the breakfast;
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years and older; * Body mass index (BMI) \> 30 kg/m2; * Sarcopenia; * not engage into exercise training programas.
Exclusion criteria
* cancer in the last 5 years; * cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form; * any disease that limits participation in exercise training program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Fat-free Mass | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage |
| Leg Fat-free Mass | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs. |
| Appendicular Fat-free Mass to Body Mass Index Ratio | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size |
| Appendicular Fat-free Mass | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Function (Gait Speed) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes. |
| Bone Mineral Density (Total Hip) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA) |
| Bone Mineral Density (Lumbar Spine) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA) |
| Bone Microarchitecture (Total Volumetric Density) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Bone Microarchitecture (Trabecular Volumetric Density) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Bone Microarchitecture (Cortical Volumetric Density) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Bone Microarchitecture (BV/TV) | 16 weeks | Bone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction. |
| Bone Microarchitecture (Trabecular Number - Tb. N) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image. |
| Bone Microarchitecture (Trabecular Separation) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images. The separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as: Tb.Sp = 1- BV/TV : Tb.N |
| Bone Microarchitecture (Trabecular Thickness) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue. The trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N |
| Bone Microarchitecture (Cortical Porosity) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening. |
| Bone Microarchitecture (Cortical Thickness) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Bone Microarchitecture (Cortical Pore Diameter) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT) |
| Bone Microarchitecture (Stiffness) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility. |
| Bone Microarchitecture (Estimated Failure Load) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior. |
| Isometric Muscle Strength - Handgrip | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA). |
| Muscle Strength - Upper Limbs | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle strength was evaluated using maximal dynamic strength test \[1RM\]) |
| Muscle Strength - Lower Limbs | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle strength was evaluated using maximal dynamic strength test \[1RM\]) |
| Muscle Function (Short Physical Performance Battery) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults. |
| Muscle Function (30-s Sit-to-stand Test) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions. |
| Muscle Function (Timed-up-and-go) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments. |
| Cardiorespiratory Fitness | 16 weeks | Cardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill |
| Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula: HOMA-IR = (fasting insulin \[µU/mL\] × fasting glucose \[mg/dL\]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually \<2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance. |
| Brachial Flow-mediated Dilation (FMD) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health. |
| Fat-mass | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage. |
| Quadriceps Cross-sectional Area (CSA) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging |
| Rectus Femoris Cross-sectional Area (CSA) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound. |
| Vastus Lateralis Cross-sectional Area (CSA) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound. |
| Muscle Fiber Cross-sectional Area (fCSA)- Type I | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy |
| Muscle Fiber Cross-sectional Area (fCSA)- Type II | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy |
| Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone turnover was assessed by an automated electrochemiluminescence method. |
| Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Bone turnover was assessed by an automated electrochemiluminescence method. |
| Bone Mineral Density (Whole-body) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA) |
| Bone Mineral Density (Femur Neck) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress - Superoxide Dismutase | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate. |
| Oxidative Stress - Catalase Activity | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength. |
| Oxidative Stress - Glutathione Peroxidase | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺. |
| Oxidative Stress - Glutathione Reductase | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay. |
| Oxidative Stress - Glutathione S-transferases | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm. |
| Oxidative Stress - Thiobarbituric Acid Reactive Substances | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress. |
| Inflammatory Profile - IL1β | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology. |
| Inflammatory Profile - IL-10 | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology. |
| Inflammatory Profile - IL-6 | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology. |
| Inflammatory Profile - TNF-α | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology. |
| Inflammatory Profile - C-Reactive Protein | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay. |
| Area Under the Curve (AUC) of Blood Glucose | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion. |
| Area Under the Curve (AUC) of Insulin | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion. |
| Anxiety | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms. |
| Depression | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression. |
| Health-related Quality of Life - Physical Component | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life. |
| Health-related Quality of Life - Mental Component | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life. |
| Sleep Quality | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
| Lipid Profile (HDL) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods |
| Lipid Profile (Triglycerides) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods |
| Lipid Profile (VLDL) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods |
| Lipid Profile (LDL) | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods |
| Telomere Length | Baseline (Pre-intervention) and 16 weeks (Post-intervention) | Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research. |
Countries
Brazil
Participant flow
Recruitment details
Recruitment started: 2021-08-01 Recruitment finished: 2023-02-26
Participants by arm
| Arm | Count |
|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast; | 35 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast; | 35 |
| Control Group (CTRL) Patients allocated to this arm did not receive any intervention. | 35 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Health issues unrelated to the trial | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 4 | 8 |
Baseline characteristics
| Characteristic | Control Group (CTRL) | Total | Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) |
|---|---|---|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 5.3 | 71.7 years STANDARD_DEVIATION 5.4 | 72.2 years STANDARD_DEVIATION 5.6 | 71.8 years STANDARD_DEVIATION 5.6 |
| Appendicular fat-free mass (kg) | 17.4 Kg STANDARD_DEVIATION 3.6 | 17.7 Kg STANDARD_DEVIATION 3.8 | 17.7 Kg STANDARD_DEVIATION 4.2 | 18.0 Kg STANDARD_DEVIATION 3.7 |
| Appendicular fat-free mass to body mass index ratio | 0.51 Kg/Kg/m^2 STANDARD_DEVIATION 0.1 | 0.51 Kg/Kg/m^2 STANDARD_DEVIATION 0.11 | 0.49 Kg/Kg/m^2 STANDARD_DEVIATION 0.12 | 0.52 Kg/Kg/m^2 STANDARD_DEVIATION 0.11 |
| Body mass index (kg/m²) | 34.5 kg/m² STANDARD_DEVIATION 4 | 35.1 kg/m² STANDARD_DEVIATION 4.4 | 36.0 kg/m² STANDARD_DEVIATION 4.8 | 34.8 kg/m² STANDARD_DEVIATION 4.5 |
| Diabetes (n) | 7 Participants | 30 Participants | 11 Participants | 12 Participants |
| Dyslipidemia (n) | 13 Participants | 44 Participants | 16 Participants | 15 Participants |
| Hypertension (n) | 23 Participants | 72 Participants | 29 Participants | 20 Participants |
| Leg fat-free mass (kg) | 13.2 Kg STANDARD_DEVIATION 2.7 | 13.4 Kg STANDARD_DEVIATION 2.9 | 13.5 Kg STANDARD_DEVIATION 3.2 | 13.5 Kg STANDARD_DEVIATION 2.7 |
| Osteopenia (n) | 21 Participants | 62 Participants | 21 Participants | 20 Participants |
| Psychiatric diseases (n) | 5 Participants | 23 Participants | 6 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment Brazil | 35 participants | 105 participants | 35 participants | 35 participants |
| Rheumatic diseases (n) | 6 Participants | 13 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 27 Participants | 81 Participants | 27 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 8 Participants | 8 Participants |
| Total fat-free mass (%) | 50.5 Percentage STANDARD_DEVIATION 5.1 | 50.2 Percentage STANDARD_DEVIATION 5.1 | 49.6 Percentage STANDARD_DEVIATION 5.4 | 50.3 Percentage STANDARD_DEVIATION 4.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 8 / 35 | 8 / 35 | 8 / 35 |
| serious Total, serious adverse events | 1 / 35 | 1 / 35 | 0 / 35 |
Outcome results
Primary
Appendicular Fat-free Mass
Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Appendicular Fat-free Mass | Pre | 17.7 Kg | Standard Deviation 4.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Appendicular Fat-free Mass | Post | 18.1 Kg | Standard Deviation 3.5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Appendicular Fat-free Mass | Pre | 18.0 Kg | Standard Deviation 3.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Appendicular Fat-free Mass | Post | 17.6 Kg | Standard Deviation 3.5 |
| Control Group (CTRL) | Appendicular Fat-free Mass | Pre | 17.4 Kg | Standard Deviation 3.6 |
| Control Group (CTRL) | Appendicular Fat-free Mass | Post | 16.5 Kg | Standard Deviation 2.7 |
p-value: <0.001Mixed Models Analysis
Primary
Appendicular Fat-free Mass to Body Mass Index Ratio
The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Appendicular Fat-free Mass to Body Mass Index Ratio | Post | 0.54 Kg/Kg/m^2 | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Appendicular Fat-free Mass to Body Mass Index Ratio | Pre | 0.49 Kg/Kg/m^2 | Standard Deviation 0.12 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Appendicular Fat-free Mass to Body Mass Index Ratio | Post | 0.54 Kg/Kg/m^2 | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Appendicular Fat-free Mass to Body Mass Index Ratio | Pre | 0.52 Kg/Kg/m^2 | Standard Deviation 0.11 |
| Control Group (CTRL) | Appendicular Fat-free Mass to Body Mass Index Ratio | Pre | 0.51 Kg/Kg/m^2 | Standard Deviation 0.1 |
| Control Group (CTRL) | Appendicular Fat-free Mass to Body Mass Index Ratio | Post | 0.48 Kg/Kg/m^2 | Standard Deviation 0.09 |
p-value: <0.001Mixed Models Analysis
Primary
Leg Fat-free Mass
Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Leg Fat-free Mass | Pre | 13.5 Kg | Standard Deviation 3.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Leg Fat-free Mass | Post | 13.8 Kg | Standard Deviation 2.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Leg Fat-free Mass | Pre | 13.5 Kg | Standard Deviation 2.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Leg Fat-free Mass | Post | 13.0 Kg | Standard Deviation 2.5 |
| Control Group (CTRL) | Leg Fat-free Mass | Pre | 13.2 Kg | Standard Deviation 2.7 |
| Control Group (CTRL) | Leg Fat-free Mass | Post | 12.5 Kg | Standard Deviation 2.2 |
p-value: 0.007Mixed Models Analysis
Primary
Percentage of Fat-free Mass
Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Percentage of Fat-free Mass | Pre | 49.6 percentage of fat-free mass | Standard Deviation 5.4 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Percentage of Fat-free Mass | Post | 52.5 percentage of fat-free mass | Standard Deviation 5.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Percentage of Fat-free Mass | Pre | 50.3 percentage of fat-free mass | Standard Deviation 4.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Percentage of Fat-free Mass | Post | 52.7 percentage of fat-free mass | Standard Deviation 4.3 |
| Control Group (CTRL) | Percentage of Fat-free Mass | Pre | 50.5 percentage of fat-free mass | Standard Deviation 5.1 |
| Control Group (CTRL) | Percentage of Fat-free Mass | Post | 49.3 percentage of fat-free mass | Standard Deviation 4.7 |
p-value: 0.013Mixed Models Analysis
Secondary
Bone Microarchitecture (BV/TV)
Bone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (BV/TV) | Post | 12.7 percentage of trabecular bone volume | Standard Deviation 3.5 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (BV/TV) | Pre | 12.5 percentage of trabecular bone volume | Standard Deviation 3.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (BV/TV) | Post | 12.9 percentage of trabecular bone volume | Standard Deviation 3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (BV/TV) | Pre | 12.9 percentage of trabecular bone volume | Standard Deviation 2.8 |
| Control Group (CTRL) | Bone Microarchitecture (BV/TV) | Post | 12.3 percentage of trabecular bone volume | Standard Deviation 3.2 |
| Control Group (CTRL) | Bone Microarchitecture (BV/TV) | Pre | 12.2 percentage of trabecular bone volume | Standard Deviation 3 |
p-value: 0.001Mixed Models Analysis
Secondary
Bone Microarchitecture (Cortical Pore Diameter)
Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Pore Diameter) | Pre | 0.168 mm | Standard Deviation 0.038 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Pore Diameter) | Post | 0.166 mm | Standard Deviation 0.038 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Pore Diameter) | Pre | 0.172 mm | Standard Deviation 0.043 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Pore Diameter) | Post | 0.174 mm | Standard Deviation 0.038 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Pore Diameter) | Pre | 0.169 mm | Standard Deviation 0.029 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Pore Diameter) | Post | 0.171 mm | Standard Deviation 0.03 |
p-value: 0.613Mixed Models Analysis
Secondary
Bone Microarchitecture (Cortical Porosity)
Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Porosity) | Pre | 3.5 percentage | Standard Deviation 2.5 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Porosity) | Post | 3.1 percentage | Standard Deviation 1.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Porosity) | Pre | 3.5 percentage | Standard Deviation 2.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Porosity) | Post | 3.4 percentage | Standard Deviation 2.6 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Porosity) | Pre | 3.2 percentage | Standard Deviation 2.4 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Porosity) | Post | 3.5 percentage | Standard Deviation 2.5 |
p-value: <0.001Mixed Models Analysis
Secondary
Bone Microarchitecture (Cortical Thickness)
Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Thickness) | Pre | 0.958 mm | Standard Deviation 0.242 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Thickness) | Post | 0.968 mm | Standard Deviation 0.24 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Thickness) | Pre | 0.827 mm | Standard Deviation 0.201 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Thickness) | Post | 0.826 mm | Standard Deviation 0.203 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Thickness) | Pre | 0.908 mm | Standard Deviation 0.193 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Thickness) | Post | 0.911 mm | Standard Deviation 0.203 |
p-value: 0.344Mixed Models Analysis
Secondary
Bone Microarchitecture (Cortical Volumetric Density)
Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Volumetric Density) | Pre | 969.9 mg HA/cm³ | Standard Deviation 59.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Cortical Volumetric Density) | Post | 969.9 mg HA/cm³ | Standard Deviation 62.5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Volumetric Density) | Pre | 951.0 mg HA/cm³ | Standard Deviation 76.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Cortical Volumetric Density) | Post | 948.7 mg HA/cm³ | Standard Deviation 76.3 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Volumetric Density) | Pre | 972.8 mg HA/cm³ | Standard Deviation 60.3 |
| Control Group (CTRL) | Bone Microarchitecture (Cortical Volumetric Density) | Post | 975.5 mg HA/cm³ | Standard Deviation 57.5 |
p-value: 0.551Mixed Models Analysis
Secondary
Bone Microarchitecture (Estimated Failure Load)
Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Estimated Failure Load) | Pre | 3458 kN | Standard Deviation 910 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Estimated Failure Load) | Post | 3503 kN | Standard Deviation 860 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Estimated Failure Load) | Pre | 3553 kN | Standard Deviation 888 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Estimated Failure Load) | Post | 3598 kN | Standard Deviation 940 |
| Control Group (CTRL) | Bone Microarchitecture (Estimated Failure Load) | Pre | 3430 kN | Standard Deviation 948 |
| Control Group (CTRL) | Bone Microarchitecture (Estimated Failure Load) | Post | 3347 kN | Standard Deviation 863 |
p-value: 0.601Mixed Models Analysis
Secondary
Bone Microarchitecture (Stiffness)
Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Stiffness) | Pre | 72.7 kN/mm | Standard Deviation 20 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Stiffness) | Post | 73.5 kN/mm | Standard Deviation 18.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Stiffness) | Pre | 74.1 kN/mm | Standard Deviation 18.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Stiffness) | Post | 75.1 kN/mm | Standard Deviation 19.6 |
| Control Group (CTRL) | Bone Microarchitecture (Stiffness) | Pre | 71.6 kN/mm | Standard Deviation 20.2 |
| Control Group (CTRL) | Bone Microarchitecture (Stiffness) | Post | 69.7 kN/mm | Standard Deviation 18.2 |
p-value: 0.944Mixed Models Analysis
Secondary
Bone Microarchitecture (Total Volumetric Density)
Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Total Volumetric Density) | Pre | 331.9 mg HA/cm³ | Standard Deviation 82 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Total Volumetric Density) | Post | 340.2 mg HA/cm³ | Standard Deviation 85.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Total Volumetric Density) | Post | 308.6 mg HA/cm³ | Standard Deviation 66.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Total Volumetric Density) | Pre | 309.5 mg HA/cm³ | Standard Deviation 58.9 |
| Control Group (CTRL) | Bone Microarchitecture (Total Volumetric Density) | Post | 328.9 mg HA/cm³ | Standard Deviation 72.9 |
| Control Group (CTRL) | Bone Microarchitecture (Total Volumetric Density) | Pre | 324.7 mg HA/cm³ | Standard Deviation 75.4 |
p-value: 0.145Mixed Models Analysis
Secondary
Bone Microarchitecture (Trabecular Number - Tb. N)
The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Number - Tb. N) | Pre | 1.86 Trabeculae per mm | Standard Deviation 0.35 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Number - Tb. N) | Post | 1.90 Trabeculae per mm | Standard Deviation 0.33 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Number - Tb. N) | Pre | 1.96 Trabeculae per mm | Standard Deviation 0.33 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Number - Tb. N) | Post | 1.93 Trabeculae per mm | Standard Deviation 0.34 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Number - Tb. N) | Pre | 1.90 Trabeculae per mm | Standard Deviation 0.38 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Number - Tb. N) | Post | 1.90 Trabeculae per mm | Standard Deviation 0.35 |
p-value: 0.001Mixed Models Analysis
Secondary
Bone Microarchitecture (Trabecular Separation)
Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images. The separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as: Tb.Sp = 1- BV/TV : Tb.N
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Separation) | Pre | 0.493 mm | Standard Deviation 0.127 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Separation) | Post | 0.474 mm | Standard Deviation 0.101 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Separation) | Pre | 0.459 mm | Standard Deviation 0.092 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Separation) | Post | 0.474 mm | Standard Deviation 0.106 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Separation) | Pre | 0.488 mm | Standard Deviation 0.132 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Separation) | Post | 0.469 mm | Standard Deviation 0.117 |
p-value: 0.001Mixed Models Analysis
Secondary
Bone Microarchitecture (Trabecular Thickness)
Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue. The trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Thickness) | Pre | 0.066 mm | Standard Deviation 0.014 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Thickness) | Post | 0.064 mm | Standard Deviation 0.013 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Thickness) | Pre | 0.066 mm | Standard Deviation 0.013 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Thickness) | Post | 0.068 mm | Standard Deviation 0.012 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Thickness) | Pre | 0.066 mm | Standard Deviation 0.012 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Thickness) | Post | 0.067 mm | Standard Deviation 0.011 |
p-value: 0.008Mixed Models Analysis
Secondary
Bone Microarchitecture (Trabecular Volumetric Density)
Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Volumetric Density) | Pre | 147.7 mg HA/cm³ | Standard Deviation 37.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Microarchitecture (Trabecular Volumetric Density) | Post | 152.0 mg HA/cm³ | Standard Deviation 37.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Volumetric Density) | Pre | 309.5 mg HA/cm³ | Standard Deviation 58.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Microarchitecture (Trabecular Volumetric Density) | Post | 308.6 mg HA/cm³ | Standard Deviation 66.8 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Volumetric Density) | Post | 328.9 mg HA/cm³ | Standard Deviation 72.9 |
| Control Group (CTRL) | Bone Microarchitecture (Trabecular Volumetric Density) | Pre | 324.7 mg HA/cm³ | Standard Deviation 75.4 |
p-value: 0.001Mixed Models Analysis
Secondary
Bone Mineral Density (Femur Neck)
bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Femur Neck) | Pre | 0.75 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Femur Neck) | Post | 0.74 g/cm² | Standard Deviation 0.12 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Femur Neck) | Pre | 0.75 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Femur Neck) | Post | 0.75 g/cm² | Standard Deviation 0.12 |
| Control Group (CTRL) | Bone Mineral Density (Femur Neck) | Post | 0.74 g/cm² | Standard Deviation 0.11 |
| Control Group (CTRL) | Bone Mineral Density (Femur Neck) | Pre | 0.74 g/cm² | Standard Deviation 0.11 |
p-value: 0.944Mixed Models Analysis
Secondary
Bone Mineral Density (Lumbar Spine)
bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Lumbar Spine) | Pre | 0.98 g/cm² | Standard Deviation 0.12 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Lumbar Spine) | Post | 0.97 g/cm² | Standard Deviation 0.12 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Lumbar Spine) | Pre | 1.01 g/cm² | Standard Deviation 0.16 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Lumbar Spine) | Post | 1.00 g/cm² | Standard Deviation 0.16 |
| Control Group (CTRL) | Bone Mineral Density (Lumbar Spine) | Pre | 0.96 g/cm² | Standard Deviation 0.15 |
| Control Group (CTRL) | Bone Mineral Density (Lumbar Spine) | Post | 0.96 g/cm² | Standard Deviation 0.14 |
p-value: 0.027Mixed Models Analysis
Secondary
Bone Mineral Density (Total Hip)
bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Total Hip) | Pre | 0.90 g/cm² | Standard Deviation 0.13 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Total Hip) | Post | 0.90 g/cm² | Standard Deviation 0.13 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Total Hip) | Pre | 0.93 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Total Hip) | Post | 0.93 g/cm² | Standard Deviation 0.12 |
| Control Group (CTRL) | Bone Mineral Density (Total Hip) | Pre | 0.89 g/cm² | Standard Deviation 0.13 |
| Control Group (CTRL) | Bone Mineral Density (Total Hip) | Post | 0.88 g/cm² | Standard Deviation 0.13 |
p-value: 0.203Mixed Models Analysis
Secondary
Bone Mineral Density (Whole-body)
bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Whole-body) | Pre | 1.08 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Bone Mineral Density (Whole-body) | Post | 1.06 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Whole-body) | Pre | 1.10 g/cm² | Standard Deviation 0.11 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Bone Mineral Density (Whole-body) | Post | 1.08 g/cm² | Standard Deviation 0.11 |
| Control Group (CTRL) | Bone Mineral Density (Whole-body) | Pre | 1.05 g/cm² | Standard Deviation 0.12 |
| Control Group (CTRL) | Bone Mineral Density (Whole-body) | Post | 1.05 g/cm² | Standard Deviation 0.11 |
p-value: 0.033Mixed Models Analysis
Secondary
Brachial Flow-mediated Dilation (FMD)
Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Brachial Flow-mediated Dilation (FMD) | Pre | 4.6 percentage of flow mediated dilatation | Standard Deviation 0.5 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Brachial Flow-mediated Dilation (FMD) | Post | 7.8 percentage of flow mediated dilatation | Standard Deviation 0.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Brachial Flow-mediated Dilation (FMD) | Pre | 4.8 percentage of flow mediated dilatation | Standard Deviation 0.5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Brachial Flow-mediated Dilation (FMD) | Post | 6.3 percentage of flow mediated dilatation | Standard Deviation 0.6 |
| Control Group (CTRL) | Brachial Flow-mediated Dilation (FMD) | Pre | 5 percentage of flow mediated dilatation | Standard Deviation 0.6 |
| Control Group (CTRL) | Brachial Flow-mediated Dilation (FMD) | Post | 2.6 percentage of flow mediated dilatation | Standard Deviation 0.6 |
p-value: <0.001Mixed Models Analysis
Secondary
Cardiorespiratory Fitness
Cardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Cardiorespiratory Fitness | Post | 19.2 mL/Kg/min | Standard Deviation 5.4 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Cardiorespiratory Fitness | Pre | 16.0 mL/Kg/min | Standard Deviation 4.4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Cardiorespiratory Fitness | Post | 20 mL/Kg/min | Standard Deviation 2.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Cardiorespiratory Fitness | Pre | 17.7 mL/Kg/min | Standard Deviation 3.2 |
| Control Group (CTRL) | Cardiorespiratory Fitness | Pre | 17.6 mL/Kg/min | Standard Deviation 3.6 |
| Control Group (CTRL) | Cardiorespiratory Fitness | Post | 17.9 mL/Kg/min | Standard Deviation 3.4 |
p-value: <0.001Mixed Models Analysis
Secondary
Fat-mass
Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Fat-mass | Pre | 48.6 percentage of fat mass | Standard Deviation 5.6 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Fat-mass | Post | 45.6 percentage of fat mass | Standard Deviation 6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Fat-mass | Pre | 47.8 percentage of fat mass | Standard Deviation 4.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Fat-mass | Post | 45.4 percentage of fat mass | Standard Deviation 4.4 |
| Control Group (CTRL) | Fat-mass | Pre | 47.7 percentage of fat mass | Standard Deviation 5.2 |
| Control Group (CTRL) | Fat-mass | Post | 48.9 percentage of fat mass | Standard Deviation 4.9 |
p-value: <0.001Mixed Models Analysis
Secondary
Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula: HOMA-IR = (fasting insulin \[µU/mL\] × fasting glucose \[mg/dL\]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually \<2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Pre | 4.2 Index | Standard Deviation 0.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Post | 2.5 Index | Standard Deviation 0.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Pre | 4.3 Index | Standard Deviation 0.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Post | 3.1 Index | Standard Deviation 0.2 |
| Control Group (CTRL) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Pre | 4.1 Index | Standard Deviation 0.1 |
| Control Group (CTRL) | Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity | Post | 3.6 Index | Standard Deviation 0.2 |
p-value: 0.017Mixed Models Analysis
Secondary
Isometric Muscle Strength - Handgrip
Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA).
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Isometric Muscle Strength - Handgrip | Pre | 18.57 Kg | Standard Deviation 5.44 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Isometric Muscle Strength - Handgrip | Post | 23.17 Kg | Standard Deviation 5.38 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Isometric Muscle Strength - Handgrip | Pre | 19.29 Kg | Standard Deviation 5.84 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Isometric Muscle Strength - Handgrip | Post | 23.71 Kg | Standard Deviation 4.82 |
| Control Group (CTRL) | Isometric Muscle Strength - Handgrip | Post | 18.43 Kg | Standard Deviation 5.07 |
| Control Group (CTRL) | Isometric Muscle Strength - Handgrip | Pre | 19.86 Kg | Standard Deviation 5.62 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Fiber Cross-sectional Area (fCSA)- Type I
Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Post | 3108.6 µm² | Standard Deviation 1212.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Pre | 2240.7 µm² | Standard Deviation 901.5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Pre | 2725.8 µm² | Standard Deviation 1121.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Post | 2859.4 µm² | Standard Deviation 948.67 |
| Control Group (CTRL) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Pre | 2669.4 µm² | Standard Deviation 806.7 |
| Control Group (CTRL) | Muscle Fiber Cross-sectional Area (fCSA)- Type I | Post | 2614.6 µm² | Standard Deviation 1076.4 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Fiber Cross-sectional Area (fCSA)- Type II
Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Pre | 2175.6 µm² | Standard Deviation 827.6 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Post | 2775.2 µm² | Standard Deviation 964.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Pre | 2401.4 µm² | Standard Deviation 1108.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Post | 2239.5 µm² | Standard Deviation 724.8 |
| Control Group (CTRL) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Pre | 2340.8 µm² | Standard Deviation 921.2 |
| Control Group (CTRL) | Muscle Fiber Cross-sectional Area (fCSA)- Type II | Post | 2166.1 µm² | Standard Deviation 979.8 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Function (30-s Sit-to-stand Test)
The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (30-s Sit-to-stand Test) | Pre | 10.3 number of repetitions | Standard Deviation 3.5 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (30-s Sit-to-stand Test) | Post | 12.8 number of repetitions | Standard Deviation 3.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (30-s Sit-to-stand Test) | Pre | 9.4 number of repetitions | Standard Deviation 3.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (30-s Sit-to-stand Test) | Post | 12.4 number of repetitions | Standard Deviation 3.5 |
| Control Group (CTRL) | Muscle Function (30-s Sit-to-stand Test) | Pre | 10.4 number of repetitions | Standard Deviation 3.1 |
| Control Group (CTRL) | Muscle Function (30-s Sit-to-stand Test) | Post | 10.2 number of repetitions | Standard Deviation 2.4 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Function (Gait Speed)
Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Gait Speed) | Pre | 0.95 m/s | Standard Deviation 0.23 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Gait Speed) | Post | 1.13 m/s | Standard Deviation 0.26 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Gait Speed) | Pre | 0.90 m/s | Standard Deviation 0.25 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Gait Speed) | Post | 1.13 m/s | Standard Deviation 0.27 |
| Control Group (CTRL) | Muscle Function (Gait Speed) | Pre | 0.98 m/s | Standard Deviation 0.18 |
| Control Group (CTRL) | Muscle Function (Gait Speed) | Post | 0.97 m/s | Standard Deviation 0.18 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Function (Short Physical Performance Battery)
Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Short Physical Performance Battery) | Post | 10.7 score on a scale | Standard Deviation 1.6 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Short Physical Performance Battery) | Pre | 8.9 score on a scale | Standard Deviation 2.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Short Physical Performance Battery) | Pre | 8.2 score on a scale | Standard Deviation 2.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Short Physical Performance Battery) | Post | 10.9 score on a scale | Standard Deviation 1.9 |
| Control Group (CTRL) | Muscle Function (Short Physical Performance Battery) | Pre | 9.3 score on a scale | Standard Deviation 1.6 |
| Control Group (CTRL) | Muscle Function (Short Physical Performance Battery) | Post | 9.0 score on a scale | Standard Deviation 1.6 |
Secondary
Muscle Function (Timed-up-and-go)
The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Timed-up-and-go) | Post | 8.49 seconds | Standard Deviation 2.97 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Function (Timed-up-and-go) | Pre | 9.76 seconds | Standard Deviation 4.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Timed-up-and-go) | Pre | 10.91 seconds | Standard Deviation 4.26 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Function (Timed-up-and-go) | Post | 9.01 seconds | Standard Deviation 4.37 |
| Control Group (CTRL) | Muscle Function (Timed-up-and-go) | Pre | 8.67 seconds | Standard Deviation 1.79 |
| Control Group (CTRL) | Muscle Function (Timed-up-and-go) | Post | 9.38 seconds | Standard Deviation 1.84 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Strength - Lower Limbs
Muscle strength was evaluated using maximal dynamic strength test \[1RM\])
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Strength - Lower Limbs | Pre | 99.9 Kg | Standard Deviation 35.6 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Strength - Lower Limbs | Post | 120.8 Kg | Standard Deviation 39.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Strength - Lower Limbs | Pre | 99.6 Kg | Standard Deviation 35.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Strength - Lower Limbs | Post | 124.8 Kg | Standard Deviation 36.5 |
| Control Group (CTRL) | Muscle Strength - Lower Limbs | Pre | 106.9 Kg | Standard Deviation 43 |
| Control Group (CTRL) | Muscle Strength - Lower Limbs | Post | 94.3 Kg | Standard Deviation 43.4 |
p-value: <0.001Mixed Models Analysis
Secondary
Muscle Strength - Upper Limbs
Muscle strength was evaluated using maximal dynamic strength test \[1RM\])
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Strength - Upper Limbs | Pre | 21.9 Kg | Standard Deviation 8.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Muscle Strength - Upper Limbs | Post | 26.9 Kg | Standard Deviation 10.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Strength - Upper Limbs | Pre | 23.2 Kg | Standard Deviation 8.4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Muscle Strength - Upper Limbs | Post | 28.1 Kg | Standard Deviation 8.7 |
| Control Group (CTRL) | Muscle Strength - Upper Limbs | Pre | 23.2 Kg | Standard Deviation 8.6 |
| Control Group (CTRL) | Muscle Strength - Upper Limbs | Post | 19.2 Kg | Standard Deviation 7.5 |
p-value: <0.001Mixed Models Analysis
Secondary
Quadriceps Cross-sectional Area (CSA)
Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Quadriceps Cross-sectional Area (CSA) | Pre | 51.7 cm² | Standard Deviation 13.4 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Quadriceps Cross-sectional Area (CSA) | Post | 54.3 cm² | Standard Deviation 13.4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Quadriceps Cross-sectional Area (CSA) | Pre | 50.7 cm² | Standard Deviation 12.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Quadriceps Cross-sectional Area (CSA) | Post | 51.9 cm² | Standard Deviation 12.9 |
| Control Group (CTRL) | Quadriceps Cross-sectional Area (CSA) | Pre | 50.1 cm² | Standard Deviation 14.4 |
| Control Group (CTRL) | Quadriceps Cross-sectional Area (CSA) | Post | 47.7 cm² | Standard Deviation 11.5 |
p-value: <0.001Mixed Models Analysis
Secondary
Rectus Femoris Cross-sectional Area (CSA)
Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Rectus Femoris Cross-sectional Area (CSA) | Pre | 3.39 cm² | Standard Deviation 1.06 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Rectus Femoris Cross-sectional Area (CSA) | Post | 3.45 cm² | Standard Deviation 1.07 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Rectus Femoris Cross-sectional Area (CSA) | Pre | 3.23 cm² | Standard Deviation 0.96 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Rectus Femoris Cross-sectional Area (CSA) | Post | 3.27 cm² | Standard Deviation 0.95 |
| Control Group (CTRL) | Rectus Femoris Cross-sectional Area (CSA) | Pre | 3.32 cm² | Standard Deviation 1.21 |
| Control Group (CTRL) | Rectus Femoris Cross-sectional Area (CSA) | Post | 3.10 cm² | Standard Deviation 0.98 |
p-value: 0.005Mixed Models Analysis
Secondary
Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
Bone turnover was assessed by an automated electrochemiluminescence method.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Pre | 0.34 ng/mL | Standard Deviation 0.19 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Post | 0.38 ng/mL | Standard Deviation 0.22 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Pre | 0.38 ng/mL | Standard Deviation 0.18 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Post | 0.46 ng/mL | Standard Deviation 0.21 |
| Control Group (CTRL) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Pre | 0.35 ng/mL | Standard Deviation 0.13 |
| Control Group (CTRL) | Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I) | Post | 0.35 ng/mL | Standard Deviation 0.12 |
p-value: <0.001Mixed Models Analysis
Secondary
Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
Bone turnover was assessed by an automated electrochemiluminescence method.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Pre | 53.1 ng/mL | Standard Deviation 21.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Post | 66.2 ng/mL | Standard Deviation 61 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Pre | 61.0 ng/mL | Standard Deviation 26.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Post | 66.1 ng/mL | Standard Deviation 32.2 |
| Control Group (CTRL) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Pre | 56.3 ng/mL | Standard Deviation 22.8 |
| Control Group (CTRL) | Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP) | Post | 56.8 ng/mL | Standard Deviation 22.7 |
p-value: 0.001Mixed Models Analysis
Secondary
Vastus Lateralis Cross-sectional Area (CSA)
Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Vastus Lateralis Cross-sectional Area (CSA) | Pre | 12.32 cm² | Standard Deviation 2.69 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Vastus Lateralis Cross-sectional Area (CSA) | Post | 12.55 cm² | Standard Deviation 2.84 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Vastus Lateralis Cross-sectional Area (CSA) | Pre | 12.15 cm² | Standard Deviation 2.84 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Vastus Lateralis Cross-sectional Area (CSA) | Post | 12.45 cm² | Standard Deviation 2.77 |
| Control Group (CTRL) | Vastus Lateralis Cross-sectional Area (CSA) | Pre | 12.13 cm² | Standard Deviation 3.53 |
| Control Group (CTRL) | Vastus Lateralis Cross-sectional Area (CSA) | Post | 11.49 cm² | Standard Deviation 2.81 |
p-value: <0.001Mixed Models Analysis
Other Pre-specified
Anxiety
Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Anxiety | Post | 4.6 score on a scale | Standard Deviation 5.1 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Anxiety | Pre | 6.8 score on a scale | Standard Deviation 5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Anxiety | Post | 5.5 score on a scale | Standard Deviation 5.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Anxiety | Pre | 6.6 score on a scale | Standard Deviation 4.8 |
| Control Group (CTRL) | Anxiety | Post | 4.0 score on a scale | Standard Deviation 4.1 |
| Control Group (CTRL) | Anxiety | Pre | 4.4 score on a scale | Standard Deviation 3.8 |
p-value: 0.0314Mixed Models Analysis
Other Pre-specified
Area Under the Curve (AUC) of Blood Glucose
The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Area Under the Curve (AUC) of Blood Glucose | Pre | 683.54 mg·min/dL |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Area Under the Curve (AUC) of Blood Glucose | Post | 599.51 mg·min/dL |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Area Under the Curve (AUC) of Blood Glucose | Pre | 641.73 mg·min/dL |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Area Under the Curve (AUC) of Blood Glucose | Post | 622.22 mg·min/dL |
| Control Group (CTRL) | Area Under the Curve (AUC) of Blood Glucose | Pre | 648.99 mg·min/dL |
| Control Group (CTRL) | Area Under the Curve (AUC) of Blood Glucose | Post | 638.20 mg·min/dL |
p-value: 0.013Mixed Models Analysis
Other Pre-specified
Area Under the Curve (AUC) of Insulin
The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Area Under the Curve (AUC) of Insulin | Post | 259.90 μU·min/mL |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Area Under the Curve (AUC) of Insulin | Pre | 442.08 μU·min/mL |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Area Under the Curve (AUC) of Insulin | Pre | 417.23 μU·min/mL |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Area Under the Curve (AUC) of Insulin | Post | 310.21 μU·min/mL |
| Control Group (CTRL) | Area Under the Curve (AUC) of Insulin | Pre | 432.69 μU·min/mL |
| Control Group (CTRL) | Area Under the Curve (AUC) of Insulin | Post | 403.40 μU·min/mL |
p-value: 0.064Mixed Models Analysis
Other Pre-specified
Depression
Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Depression | Pre | 4.1 score on a scale | Standard Deviation 2.9 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Depression | Post | 2.6 score on a scale | Standard Deviation 2.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Depression | Pre | 4.8 score on a scale | Standard Deviation 3.4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Depression | Post | 2.6 score on a scale | Standard Deviation 2.8 |
| Control Group (CTRL) | Depression | Pre | 2.8 score on a scale | Standard Deviation 4.4 |
| Control Group (CTRL) | Depression | Post | 2.5 score on a scale | Standard Deviation 4 |
p-value: 0.0147Mixed Models Analysis
Other Pre-specified
Health-related Quality of Life - Mental Component
Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Health-related Quality of Life - Mental Component | Pre | 59.3 score on a scale | Standard Deviation 22.4 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Health-related Quality of Life - Mental Component | Post | 74.8 score on a scale | Standard Deviation 17.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Health-related Quality of Life - Mental Component | Pre | 58.9 score on a scale | Standard Deviation 23.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Health-related Quality of Life - Mental Component | Post | 81.5 score on a scale | Standard Deviation 13.4 |
| Control Group (CTRL) | Health-related Quality of Life - Mental Component | Pre | 63.0 score on a scale | Standard Deviation 19 |
| Control Group (CTRL) | Health-related Quality of Life - Mental Component | Post | 64.5 score on a scale | Standard Deviation 21.1 |
p-value: <0.001Mixed Models Analysis
Other Pre-specified
Health-related Quality of Life - Physical Component
Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Health-related Quality of Life - Physical Component | Pre | 61.2 score on a scale | Standard Deviation 24.3 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Health-related Quality of Life - Physical Component | Post | 77.2 score on a scale | Standard Deviation 19.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Health-related Quality of Life - Physical Component | Pre | 63.9 score on a scale | Standard Deviation 22.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Health-related Quality of Life - Physical Component | Post | 77.2 score on a scale | Standard Deviation 19.5 |
| Control Group (CTRL) | Health-related Quality of Life - Physical Component | Pre | 71.8 score on a scale | Standard Deviation 19.7 |
| Control Group (CTRL) | Health-related Quality of Life - Physical Component | Post | 75.6 score on a scale | Standard Deviation 18.3 |
p-value: 0.007Mixed Models Analysis
Other Pre-specified
Inflammatory Profile - C-Reactive Protein
Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - C-Reactive Protein | Pre | 5.76 pg/mL | Standard Deviation 0.79 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - C-Reactive Protein | Post | 4.25 pg/mL | Standard Deviation 0.87 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - C-Reactive Protein | Pre | 5.19 pg/mL | Standard Deviation 0.81 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - C-Reactive Protein | Post | 5.74 pg/mL | Standard Deviation 0.86 |
| Control Group (CTRL) | Inflammatory Profile - C-Reactive Protein | Post | 5.54 pg/mL | Standard Deviation 0.87 |
| Control Group (CTRL) | Inflammatory Profile - C-Reactive Protein | Pre | 6.01 pg/mL | Standard Deviation 0.83 |
p-value: 0.469Mixed Models Analysis
Other Pre-specified
Inflammatory Profile - IL-10
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL-10 | Pre | 3.75 pg/mL | Standard Deviation 0.75 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL-10 | Post | 3.78 pg/mL | Standard Deviation 0.75 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL-10 | Pre | 4.46 pg/mL | Standard Deviation 0.76 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL-10 | Post | 2.47 pg/mL | Standard Deviation 0.76 |
| Control Group (CTRL) | Inflammatory Profile - IL-10 | Pre | 3.56 pg/mL | Standard Deviation 0.77 |
| Control Group (CTRL) | Inflammatory Profile - IL-10 | Post | 3.96 pg/mL | Standard Deviation 0.77 |
p-value: 0.239Mixed Models Analysis
Other Pre-specified
Inflammatory Profile - IL1β
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL1β | Pre | 1.45 pg/mL | Standard Deviation 0.37 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL1β | Post | 1.46 pg/mL | Standard Deviation 0.37 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL1β | Pre | 1.33 pg/mL | Standard Deviation 0.37 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL1β | Post | 0.88 pg/mL | Standard Deviation 0.37 |
| Control Group (CTRL) | Inflammatory Profile - IL1β | Pre | 1.01 pg/mL | Standard Deviation 0.38 |
| Control Group (CTRL) | Inflammatory Profile - IL1β | Post | 1.22 pg/mL | Standard Deviation 0.38 |
p-value: 0.385Mixed Models Analysis
Other Pre-specified
Inflammatory Profile - IL-6
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL-6 | Pre | 3.30 pg/mL | Standard Deviation 0.46 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - IL-6 | Post | 2.49 pg/mL | Standard Deviation 0.46 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL-6 | Pre | 2.99 pg/mL | Standard Deviation 0.46 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - IL-6 | Post | 2.49 pg/mL | Standard Deviation 0.46 |
| Control Group (CTRL) | Inflammatory Profile - IL-6 | Pre | 2.92 pg/mL | Standard Deviation 0.47 |
| Control Group (CTRL) | Inflammatory Profile - IL-6 | Post | 3.25 pg/mL | Standard Deviation 0.47 |
p-value: 0.463Mixed Models Analysis
Other Pre-specified
Inflammatory Profile - TNF-α
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - TNF-α | Pre | 20.1 pg/mL | Standard Deviation 1.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Inflammatory Profile - TNF-α | Post | 14.7 pg/mL | Standard Deviation 1.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - TNF-α | Pre | 19.6 pg/mL | Standard Deviation 1.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Inflammatory Profile - TNF-α | Post | 15.5 pg/mL | Standard Deviation 1.2 |
| Control Group (CTRL) | Inflammatory Profile - TNF-α | Pre | 19.4 pg/mL | Standard Deviation 1.2 |
| Control Group (CTRL) | Inflammatory Profile - TNF-α | Post | 20.1 pg/mL | Standard Deviation 1.2 |
p-value: 0.032Mixed Models Analysis
Other Pre-specified
Lipid Profile (HDL)
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (HDL) | Pre | 52.1 mg/dL | Standard Deviation 0.9 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (HDL) | Post | 51.4 mg/dL | Standard Deviation 0.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (HDL) | Pre | 52.8 mg/dL | Standard Deviation 0.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (HDL) | Post | 51.5 mg/dL | Standard Deviation 0.9 |
| Control Group (CTRL) | Lipid Profile (HDL) | Pre | 52.8 mg/dL | Standard Deviation 0.9 |
| Control Group (CTRL) | Lipid Profile (HDL) | Post | 51.7 mg/dL | Standard Deviation 0.9 |
p-value: 0.949Mixed Models Analysis
Other Pre-specified
Lipid Profile (LDL)
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (LDL) | Post | 111.1 mg/dL | Standard Deviation 3.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (LDL) | Pre | 116.1 mg/dL | Standard Deviation 3.4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (LDL) | Post | 111.4 mg/dL | Standard Deviation 3.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (LDL) | Pre | 115.5 mg/dL | Standard Deviation 3.5 |
| Control Group (CTRL) | Lipid Profile (LDL) | Post | 112.3 mg/dL | Standard Deviation 3.7 |
| Control Group (CTRL) | Lipid Profile (LDL) | Pre | 116.8 mg/dL | Standard Deviation 3.5 |
p-value: 0.993Mixed Models Analysis
Other Pre-specified
Lipid Profile (Triglycerides)
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (Triglycerides) | Post | 119.0 mg/dL | Standard Deviation 5.3 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (Triglycerides) | Pre | 140.4 mg/dL | Standard Deviation 4.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (Triglycerides) | Post | 122.5 mg/dL | Standard Deviation 5.3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (Triglycerides) | Pre | 141.1 mg/dL | Standard Deviation 5 |
| Control Group (CTRL) | Lipid Profile (Triglycerides) | Pre | 138.8 mg/dL | Standard Deviation 5.1 |
| Control Group (CTRL) | Lipid Profile (Triglycerides) | Post | 130.8 mg/dL | Standard Deviation 5.4 |
p-value: 0.408Mixed Models Analysis
Other Pre-specified
Lipid Profile (VLDL)
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (VLDL) | Pre | 25.2 mg/dL | Standard Deviation 0.7 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Lipid Profile (VLDL) | Post | 22.8 mg/dL | Standard Deviation 0.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (VLDL) | Pre | 25.4 mg/dL | Standard Deviation 0.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Lipid Profile (VLDL) | Post | 22.8 mg/dL | Standard Deviation 0.8 |
| Control Group (CTRL) | Lipid Profile (VLDL) | Pre | 25.1 mg/dL | Standard Deviation 0.7 |
| Control Group (CTRL) | Lipid Profile (VLDL) | Post | 23.9 mg/dL | Standard Deviation 0.8 |
p-value: 0.601Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Catalase Activity
Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Catalase Activity | Pre | 6.2 U/mL | Standard Deviation 2.3 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Catalase Activity | Post | 6.0 U/mL | Standard Deviation 2.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Catalase Activity | Pre | 6.6 U/mL | Standard Deviation 0.8 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Catalase Activity | Post | 6.8 U/mL | Standard Deviation 0.8 |
| Control Group (CTRL) | Oxidative Stress - Catalase Activity | Pre | 5.8 U/mL | Standard Deviation 2.7 |
| Control Group (CTRL) | Oxidative Stress - Catalase Activity | Post | 5.7 U/mL | Standard Deviation 2.3 |
p-value: 0.7Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Glutathione Peroxidase
Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione Peroxidase | Pre | 404.2 µmol GSH/min/mL | Standard Deviation 52.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione Peroxidase | Post | 416.3 µmol GSH/min/mL | Standard Deviation 45.7 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione Peroxidase | Pre | 406.5 µmol GSH/min/mL | Standard Deviation 49.5 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione Peroxidase | Post | 412.5 µmol GSH/min/mL | Standard Deviation 47.9 |
| Control Group (CTRL) | Oxidative Stress - Glutathione Peroxidase | Pre | 401.2 µmol GSH/min/mL | Standard Deviation 40.7 |
| Control Group (CTRL) | Oxidative Stress - Glutathione Peroxidase | Post | 396.1 µmol GSH/min/mL | Standard Deviation 39 |
p-value: 0.254Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Glutathione Reductase
Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione Reductase | Pre | 48.7 µmol NADPH/min/mL | Standard Deviation 3.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione Reductase | Post | 49.6 µmol NADPH/min/mL | Standard Deviation 4.2 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione Reductase | Pre | 48.0 µmol NADPH/min/mL | Standard Deviation 3 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione Reductase | Post | 47.3 µmol NADPH/min/mL | Standard Deviation 4.8 |
| Control Group (CTRL) | Oxidative Stress - Glutathione Reductase | Post | 49.1 µmol NADPH/min/mL | Standard Deviation 2.5 |
| Control Group (CTRL) | Oxidative Stress - Glutathione Reductase | Pre | 48.4 µmol NADPH/min/mL | Standard Deviation 2.4 |
p-value: 0.373Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Glutathione S-transferases
Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione S-transferases | Pre | 17.4 pmol GSH conjugates/min/mL | Standard Deviation 6.5 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Glutathione S-transferases | Post | 21.3 pmol GSH conjugates/min/mL | Standard Deviation 7.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione S-transferases | Pre | 18.7 pmol GSH conjugates/min/mL | Standard Deviation 11.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Glutathione S-transferases | Post | 19.8 pmol GSH conjugates/min/mL | Standard Deviation 9.6 |
| Control Group (CTRL) | Oxidative Stress - Glutathione S-transferases | Pre | 18.3 pmol GSH conjugates/min/mL | Standard Deviation 9.3 |
| Control Group (CTRL) | Oxidative Stress - Glutathione S-transferases | Post | 18.6 pmol GSH conjugates/min/mL | Standard Deviation 9.2 |
p-value: 0.407Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Superoxide Dismutase
Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Superoxide Dismutase | Pre | 22.6 percentage inhibition per 2 µL of samp | Standard Deviation 5.8 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Superoxide Dismutase | Post | 23.2 percentage inhibition per 2 µL of samp | Standard Deviation 4.9 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Superoxide Dismutase | Pre | 21.5 percentage inhibition per 2 µL of samp | Standard Deviation 4 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Superoxide Dismutase | Post | 23.3 percentage inhibition per 2 µL of samp | Standard Deviation 4.1 |
| Control Group (CTRL) | Oxidative Stress - Superoxide Dismutase | Post | 22.6 percentage inhibition per 2 µL of samp | Standard Deviation 4.5 |
| Control Group (CTRL) | Oxidative Stress - Superoxide Dismutase | Pre | 21.5 percentage inhibition per 2 µL of samp | Standard Deviation 5.5 |
p-value: 0.55Mixed Models Analysis
Other Pre-specified
Oxidative Stress - Thiobarbituric Acid Reactive Substances
Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Pre | 2.05 µmol/L | Standard Deviation 0.93 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Post | 1.97 µmol/L | Standard Deviation 0.84 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Post | 2.15 µmol/L | Standard Deviation 1.21 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Pre | 2.06 µmol/L | Standard Deviation 1.2 |
| Control Group (CTRL) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Post | 2.25 µmol/L | Standard Deviation 0.97 |
| Control Group (CTRL) | Oxidative Stress - Thiobarbituric Acid Reactive Substances | Pre | 1.94 µmol/L | Standard Deviation 0.52 |
p-value: 0.051Mixed Models Analysis
Other Pre-specified
Sleep Quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Sleep Quality | Pre | 5.9 score on a scale | Standard Deviation 3.2 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Sleep Quality | Post | 4.6 score on a scale | Standard Deviation 3.1 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Sleep Quality | Pre | 7.2 score on a scale | Standard Deviation 3.6 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Sleep Quality | Post | 3.6 score on a scale | Standard Deviation 2.1 |
| Control Group (CTRL) | Sleep Quality | Pre | 5.6 score on a scale | Standard Deviation 3 |
| Control Group (CTRL) | Sleep Quality | Post | 5.0 score on a scale | Standard Deviation 3.7 |
p-value: 0.001Mixed Models Analysis
Other Pre-specified
Telomere Length
Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research.
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Telomere Length | Pre | 0.98 Ratio | Standard Deviation 0.05 |
| Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) | Telomere Length | Post | 0.99 Ratio | Standard Deviation 0.06 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Telomere Length | Post | 0.99 Ratio | Standard Deviation 0.04 |
| Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) | Telomere Length | Pre | 0.97 Ratio | Standard Deviation 0.05 |
| Control Group (CTRL) | Telomere Length | Post | 0.99 Ratio | Standard Deviation 0.05 |
| Control Group (CTRL) | Telomere Length | Pre | 0.99 Ratio | Standard Deviation 0.05 |
p-value: 0.082Mixed Models Analysis