Aging, Bone Loss, Dietary Habits, Diet Modification, Fractures, Bone, Obesity, Osteopenia, Osteoporosis, Weight Change, Body, Weight Loss
Conditions
Brief summary
This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on bone phenotypes in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Detailed description
The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese (body mass index \[BMI\] 30-45 kg/m2 or 27-\<30 kg/m2 with an obesity-related risk factor), older (65-85 years) men and women at risk for disability (Short Physical Performance Battery, SPPB ≤10) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body weight/day) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves bone phenotypes compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of bone. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Vertebral and femoral volumetric bone mineral density and cortical thickness (Primary Aim) and bone marrow adipose tissue (Secondary Aim 1) will be assessed with computed tomography at baseline, 6-, and 18-months. Bone strength and fracture risk (Secondary Aim 2) will be assessed by finite element modeling at baseline, 6-, and 18-months.
Interventions
BEHAVIORALWeight loss intervention months 0-6
All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \ 10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).
BEHAVIORALExercise intervention months 0-6
All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.
DIETARY_SUPPLEMENTNutraBio™ CarboMax Supplement
Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, \ 50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.
DIETARY_SUPPLEMENT6-month NutraBio™ 100% Whey Protein Isolate Supplement
Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \ 50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.
DIETARY_SUPPLEMENT18-month NutraBio™ 100% Whey Protein Isolate Supplement
Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \ 50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Subjects are recruited using inclusion and
Exclusion criteria
of the parent trial (UPLIFT; NCT03074643). Inclusion Criteria: * 65-85 years * BMI: 30-45 kg/m2 or BMI 27.0 - \<30.0 AND at least one of the following risk factors: 1. elevated waist circumference (\>35 inches in women, \>40 inches in men) 2. diabetes, 3. hypertension, 4. dyslipidemia, 5. or other obesity-related comorbidities: clinically manifest coronary artery disease \[e.g., history of myocardial infarction, angina pectoris, coronary artery surgery, coronary artery procedures (e.g., angioplasty) if not within the past year\], other atherosclerotic disease \[e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease if not within the past year\], sleep apnea, or osteoarthritis of the knee or hip. * No regular resistance training and/or aerobic exercise (\>20 mins/d) for past 6 months * SPPB ≥3 to ≤10 * No contraindications for safe and optimal participation in exercise training * Approved for participation by Medical Director (Dr. Lyles) * Willing to provide informed consent * Agree to all study procedures and assessments * Willing to consume protein/CHO supplements for up to 18 months * Able to provide own transportation to study visits and intervention sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | Change from Baseline to Month 18 | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | Change from Baseline to Month 18 | Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 18-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 18-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure. |
| 6-month Change From Baseline in Femoral Bone Strength in kN | Change from Baseline to Month 6 | Subject-specific finite element models were created from the baseline and 6-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral bone strength. |
| 18-month Change From Baseline in Femoral Bone Strength in kN | Change from Baseline to Month 18 | Subject-specific finite element models were created from the baseline and 18-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral bone strength. |
| 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | Change from Baseline to Month 18 | Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 18-month CT scans, and the 18-month change from baseline (in mm) is reported for this outcome measure. |
| 6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | Change from Baseline to Month 6 | Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 6-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 6-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure. |
| 18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | Change from Baseline to Month 18 | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 18-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure. |
| 6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | Change from Baseline to Month 6 | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 6-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure. |
| 6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | Change from Baseline to Month 6 | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 6-month change in total hip trabecular vBMD from baseline is reported for this outcome measure. |
| 6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | Change from Baseline to Month 6 | Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 6-month CT scans, and the 6-month change from baseline (in mm) is reported for this outcome measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RecProt Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \
10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \
50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention. | 62 |
| 6-mo HiProt Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \
10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention. | 62 |
| 18-mo HiProt Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \
10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months. | 63 |
| Total | 187 |
Baseline characteristics
| Characteristic | Total | 18-mo HiProt | 6-mo HiProt | RecProt |
|---|---|---|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 4.3 | 70.5 years STANDARD_DEVIATION 3.9 | 71.8 years STANDARD_DEVIATION 4.5 | 70.7 years STANDARD_DEVIATION 4.4 |
| Body mass index (BMI) | 34.2 kg/m^2 STANDARD_DEVIATION 4.1 | 34.3 kg/m^2 STANDARD_DEVIATION 4.2 | 34.3 kg/m^2 STANDARD_DEVIATION 3.5 | 33.8 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 186 Participants | 63 Participants | 62 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 19 Participants | 14 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 138 Participants | 43 Participants | 47 Participants | 48 Participants |
| Sex: Female, Male Female | 124 Participants | 42 Participants | 41 Participants | 41 Participants |
| Sex: Female, Male Male | 63 Participants | 21 Participants | 21 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 62 | 0 / 63 |
| other Total, other adverse events | 17 / 62 | 14 / 62 | 11 / 63 |
| serious Total, serious adverse events | 8 / 62 | 5 / 62 | 5 / 63 |
Outcome results
Primary
18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 18
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | -0.91 mg/cm^3 | Standard Error 1.34 |
| 6-mo HiProt | 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | -1.77 mg/cm^3 | Standard Error 1.4 |
| 18-mo HiProt | 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | -0.03 mg/cm^3 | Standard Error 1.44 |
p-value: 0.488ANCOVA
p-value: 0.1683ANCOVA
Secondary
18-month Change From Baseline in Femoral Bone Strength in kN
Subject-specific finite element models were created from the baseline and 18-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral bone strength.
Time frame: Change from Baseline to Month 18
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 18-month Change From Baseline in Femoral Bone Strength in kN | -0.02 kN | Standard Error 0.1 |
| 6-mo HiProt | 18-month Change From Baseline in Femoral Bone Strength in kN | 0.03 kN | Standard Error 0.11 |
| 18-mo HiProt | 18-month Change From Baseline in Femoral Bone Strength in kN | 0.09 kN | Standard Error 0.11 |
p-value: 0.2422ANCOVA
p-value: 0.5082ANCOVA
Secondary
18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 18-month CT scans, and the 18-month change from baseline (in mm) is reported for this outcome measure.
Time frame: Change from Baseline to Month 18
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | 0.02 mm | Standard Error 0.02 |
| 6-mo HiProt | 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | 0.02 mm | Standard Error 0.02 |
| 18-mo HiProt | 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | 0.01 mm | Standard Error 0.03 |
p-value: 0.5119ANCOVA
p-value: 0.4902ANCOVA
Secondary
18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm
Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 18-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 18-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 18
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | -0.20 percentage of bone marrow adiposity | Standard Error 3.69 |
| 6-mo HiProt | 18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | -9.96 percentage of bone marrow adiposity | Standard Error 3.8 |
| 18-mo HiProt | 18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | -5.17 percentage of bone marrow adiposity | Standard Error 3.93 |
p-value: 0.1584ANCOVA
p-value: 0.1623ANCOVA
Secondary
18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 18-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 18
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | -1.40 mg/cm^3 | Standard Error 1.48 |
| 6-mo HiProt | 18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | -0.39 mg/cm^3 | Standard Error 1.54 |
| 18-mo HiProt | 18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | -2.59 mg/cm^3 | Standard Error 1.57 |
p-value: 0.3685ANCOVA
p-value: 0.0894ANCOVA
Secondary
6-month Change From Baseline in Femoral Bone Strength in kN
Subject-specific finite element models were created from the baseline and 6-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral bone strength.
Time frame: Change from Baseline to Month 6
Population: The two protein supplement groups (6-mo HiProt and 18-mo HiProt) are combined into a single HiProt group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 6-month Change From Baseline in Femoral Bone Strength in kN | -0.02 kN | Standard Error 0.08 |
| 6-mo HiProt | 6-month Change From Baseline in Femoral Bone Strength in kN | 0.10 kN | Standard Error 0.07 |
p-value: 0.035ANCOVA
Secondary
6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 6-month CT scans, and the 6-month change from baseline (in mm) is reported for this outcome measure.
Time frame: Change from Baseline to Month 6
Population: The two protein supplement groups (6-mo HiProt and 18-mo HiProt) are combined into a single HiProt group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | 0.01 mm | Standard Error 0.02 |
| 6-mo HiProt | 6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm | 0.01 mm | Standard Error 0.02 |
p-value: 0.85ANCOVA
Secondary
6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm
Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 6-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 6-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 6
Population: The two protein supplement groups (6-mo HiProt and 18-mo HiProt) are combined into a single HiProt group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | 7.42 percentage of bone marrow adiposity | Standard Error 4.06 |
| 6-mo HiProt | 6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm | 6.45 percentage of bone marrow adiposity | Standard Error 3.81 |
p-value: 0.7636ANCOVA
Secondary
6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 6-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 6
Population: The two protein supplement groups (6-mo HiProt and 18-mo HiProt) are combined into a single HiProt group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | 0.34 mg/cm^3 | Standard Error 1.12 |
| 6-mo HiProt | 6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 | 1.59 mg/cm^3 | Standard Error 1.05 |
p-value: 0.1573ANCOVA
Secondary
6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 6-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure.
Time frame: Change from Baseline to Month 6
Population: The two protein supplement groups (6-mo HiProt and 18-mo HiProt) are combined into a single HiProt group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RecProt | 6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | 2.87 mg/cm^3 | Standard Error 1.48 |
| 6-mo HiProt | 6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 | 3.56 mg/cm^3 | Standard Error 1.41 |
p-value: 0.5334ANCOVA