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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00038668 | Other Identifier | Wake Forest University IRB | |
| K25AG058804 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RecProt | Active Comparator | Subjects receiving the following interventions in the parent trial (UPLIFT; 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. |
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| 6-mo HiProt | Active Comparator | Subjects receiving the following interventions in the parent trial (UPLIFT; 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. |
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| 18-mo HiProt | Active Comparator | Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss intervention months 0-6 | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Weaver, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Research Center at Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2022 | Oct 20, 2023 |
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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).
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| Exercise intervention months 0-6 | Behavioral | 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. |
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| NutraBio™ CarboMax Supplement | Dietary 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. |
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| 6-month NutraBio™ 100% Whey Protein Isolate Supplement | Dietary 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. |
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| 18-month NutraBio™ 100% Whey Protein Isolate Supplement | Dietary 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. |
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| Change from Baseline to Month 6 |
| 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. | Change from Baseline to Month 18 |
| 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. | Change from Baseline to Month 6 |
| 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. | Change from Baseline to Month 18 |
| 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. | Change from Baseline to Month 18 |
| 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. | Change from Baseline to Month 6 |
| 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. | Change from Baseline to Month 18 |
| 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. | Change from Baseline to Month 6 |
| 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. | Change from Baseline to Month 6 |
| FG001 | 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. |
| FG002 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Least Squares Mean | Standard Error | mg/cm^3 | Change from Baseline to Month 18 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage of bone marrow adiposity | Change from Baseline to Month 6 |
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| 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. | Posted | Least Squares Mean | Standard Error | percentage of bone marrow adiposity | Change from Baseline to Month 18 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | kN | Change from Baseline to Month 6 |
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| 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. | Posted | Least Squares Mean | Standard Error | kN | Change from Baseline to Month 18 |
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| 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. | Posted | Least Squares Mean | Standard Error | mm | Change from Baseline to Month 18 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mm | Change from Baseline to Month 6 |
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| 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. | Posted | Least Squares Mean | Standard Error | mg/cm^3 | Change from Baseline to Month 18 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mg/cm^3 | Change from Baseline to Month 6 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mg/cm^3 | Change from Baseline to Month 6 |
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18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 62 | 8 | 62 | 17 | 62 |
| EG001 | 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. | 0 | 62 | 5 | 62 | 14 | 62 |
| EG002 | 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. | 0 | 63 | 5 | 63 | 11 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemolysis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anaphylaxis | Immune system disorders | Non-systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cognitive Disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Knee Replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Transurethral Resection Of Prostrate | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Shoulder Replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Revision of Knee Replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hip Replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Umbilical Hernia Repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Reverse Shoulder Arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
We initially planned to end recruitment in August of 2020. However, our institution paused all in-person research from March 13, 2020 through May 31, 2020 due to the COVID19 pandemic. We extended our recruitment window through September 2020 but did not reach our target enrollment. The COVID19 pandemic also affected participant follow-up (a large number of out of window visits and a few who refused to return for in-person visits). The 6-month intervention also had to go remote for ~4 months.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley Weaver, PhD | Wake Forest University Health Sciences | 336-716-0944 | asweaver@wakehealth.edu |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Nov 6, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2021 | Sep 27, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D005247 | Feeding Behavior |
| D001851 | Bone Diseases, Metabolic |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.1683 |
| Superiority |
| OG001 | 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). 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. |
|
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| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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). 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. |
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| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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). 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. |
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| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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). 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. |
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| OG001 | 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). 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. |
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