Aging, Obesity, Nutrition, Exercise, Telomere Shortening, Inflammation, Oxidative Stress, Oxidative DNA Damage
Conditions
Keywords
aging, obesity, nutrition, nutrition counseling, exercise, combined exercise, telomere, senescence
Brief summary
The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase.
Detailed description
The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase. During the intervention period, dietary recalls will be collected before and after NC, as well as midway and at the end of the CT period. Additionally, baseline assessments, midway assessments, and post-CT assessments will be conducted to evaluate functional capacity, conduct anthropometric measurements, and collect 24-hour urine and blood samples for genetic and metabolic evaluations, providing a comprehensive view of the effects of the proposed interventions.
Interventions
OTHERCombined Training
20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week
OTHERNutritional Counseling
9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This clinical trial employs a randomized controlled design to investigate the efficacy of nutritional counseling and combined exercise on elderly women who are eutrophic or obese. The study will include 80 participants recruited from Ribeirão Preto, SP, Brazil. Eutrophic participants will be randomly assigned to two groups: one receiving 20 weeks of combined exercise following nutritional counseling, and a control group receiving only nutritional counseling. Similarly, obese participants will be randomized into these same two groups. Thus, there will be four groups in total: two comprising obese women (one intervention and one control), and two comprising eutrophic women (one intervention and one control).
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* being female; * between 60 and 75 years old; * a BMI between 22 and 40 kg/m²; * being sedentary (not exercising for at least 3 months).
Exclusion criteria
* a history of cancer, autoimmune or neurodegenerative diseases; * excessive alcohol consumption; * smoking * score ≤13 on the Mini-Mental State Examination (MMSE).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR | 9 and 29 weeks | To evaluate the effect of obesity, nutritional counseling, and combined physical training on leukocyte telomere length in elderly women. Telomere length will be measured in peripheral blood mononuclear cells (PBMCs) using quantitative real-time PCR (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio according to the Cawthon method. |
| Expression of cellular senescence-related genes in PBMCs measured by quantitative RT-PCR | 9 and 29 weeks | To assess the effect of obesity, nutritional counseling, and combined physical training on the expression of genes related to cellular senescence in peripheral blood mononuclear cells (PBMCs). Gene expression will be quantified by reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene. |
| Adequacy of protein intake assessed by dietary intake analysis | 0, 9 and 29 weeks | To evaluate the effect of nutritional counseling on protein intake adequacy in elderly women. Dietary intake will be assessed using 24-hour dietary recalls, and protein intake will be calculated using nutritional analysis software. Adequacy will be determined by comparing individual protein intake with recommended intake values for older adults. |
| Percentage of ultra-processed food consumption assessed by NOVA food classification | 0, 9 and 29 weeks | To evaluate the effect of nutritional counseling on the consumption of ultra-processed foods in elderly women. Dietary intake will be assessed using 24-hour dietary recalls. Foods will be classified according to the NOVA food classification system, and the proportion of total energy intake derived from ultra-processed foods will be calculated. |
| Diet quality assessed by proportion of ultra-processed food consumption according to the NOVA classification | 0, 9 and 29 weeks | To assess the effect of nutritional counseling on diet quality in elderly women based on the degree of food processing. Dietary intake will be evaluated using 24-hour dietary recalls, and foods will be classified according to the NOVA classification system. Diet quality will be determined by calculating the proportion of total energy intake derived from ultra-processed foods, with higher values indicating poorer diet quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of telomere-related genes measured by RT-qPCR | 9 and 29 weeks | To evaluate the expression of genes associated with telomere regulation in peripheral blood mononuclear cells (PBMCs). Gene expression will be quantified using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene. |
| Expression of cellular senescence-associated genes in peripheral blood mononuclear cells measured by RT-qPCR | 9 and 29 weeks | To evaluate the expression of genes associated with cellular senescence in peripheral blood mononuclear cells (PBMCs) collected from elderly women participating in the study. Gene expression will be quantified using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene. The analyzed genes include markers involved in cellular senescence pathways such as cell cycle regulation, inflammatory response, growth signaling, and tissue remodeling. |
| Redox state analysis; | 9 and 29 weeks | Assessment of redox status, DNA damage, and activity of enzymes associated with the redox system |
| Analysis of mitochondrial function | 9 and 29 weeks | Analysis of the expression of genes associated with mitochondrial functionality and biogenesis |
| Determination of nitrogen balance | 9 and 29 weeks | Determination of nitrogen balance through estimation of protein intake through 24-hour dietary recall and nitrogen excretion obtained through 24-hour urine samples |
| Cardiorespiratory capacity assessed by incremental cycling test with blood lactate measurement | 9 and 29 weeks | To evaluate cardiorespiratory capacity using an incremental exercise test performed on a cycle ergometer. Capillary blood samples will be collected during the test to determine blood lactate concentration and identify the lactate threshold. |
| Lower limb muscle strength assessed by isokinetic dynamometry | 9 and 29 weeks | To evaluate lower limb muscle strength using an isokinetic dynamometer. Maximal voluntary torque of the knee extensors and flexors will be measured under standardized testing conditions. |
| Upper body functional strength assessed by the arm curl test | 9 and 29 weeks | To evaluate upper body functional strength using the arm curl test, which measures the number of arm curls performed within 30 seconds using a standardized weight. |
| Functional mobility assessed by the Timed Up and Go test | 9 and 29 weeks | To assess functional mobility using the Timed Up and Go (TUG) test, which measures the time required for a participant to stand up from a chair, walk three meters, turn, return to the chair, and sit down. |
| Handgrip strength measured using a hand dynamometer | 9 and 29 weeks | To evaluate maximal isometric handgrip strength using a calibrated hand dynamometer |
| Body composition assessed by dual-energy X-ray absorptiometry (DXA) | 9 and 29 weeks | To evaluate body composition in elderly women using dual-energy X-ray absorptiometry (DXA) with an iDXA scanner. Body composition parameters including total body fat mass and lean mass will be obtained from the DXA analysis. |
| Body mass index calculated from measured weight and height | 9 and 29 weeks | To assess body mass index (BMI) in elderly women. Body weight will be measured using a calibrated digital scale and height will be measured using a stadiometer following standardized anthropometric procedures. BMI will be calculated as body weight in kilograms divided by the square of height in meters. |
| Waist-to-hip ratio calculated from anthropometric measurements | 9 and 29 weeks | To assess body fat distribution using the waist-to-hip ratio (WHR). Waist and hip circumferences will be measured using a non-elastic flexible measuring tape according to standardized anthropometric procedures. The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. |
Countries
Brazil
Contacts
STUDY_DIRECTOREllen C de Freitas, PhD
Professor and researcher
Outcome results
None listed