- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819478
Utilizing Protein During Weight Loss to Impact Physical Function and Bone (UPLIFT-Bone)
Effect of Protein Supplementation During Weight Loss on Older Adult Bone Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Geriatric Research Center at Wake Forest Baptist Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- elevated waist circumference (>35 inches in women, >40 inches in men)
- diabetes,
- hypertension,
- dyslipidemia,
- 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
Exclusion Criteria:
- Weight loss (≥5%) in past 6 months
- Dependent on cane or walker
- Cognitive impairment (Montreal Cognitive Assessment, MoCA score <22)
- Severe arthritis, or other musculoskeletal disorder
- Joint replacement or other orthopedic surgery in past year
- Uncontrolled resting hypertension (>160/90 mmHg);
- Uncontrolled diabetes (hemoglobin A1c, HbA1c ≥8.0%)
- Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled endocrine/metabolic disease; neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers; liver or renal disease; or clinically evident edema
- Unstable Severe Depression
- Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm at rest or ≥2 mm with exercise)
- Abnormal kidney function (estimated glomerular rate <30 based on serum creatinine, age, gender, and race)
- Anemia (Hb<13 g/dL in men; <12 g/dL in women)
- Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men)
- Use of any tobacco or nicotine products in the past year
- Osteoporosis (T-score < -2.5 on hip or spine scan)
- Regular use of growth/steroid hormones, sex steroids or corticosteroids
- Osteoporosis medication
- Protein supplements (and unwilling to stop using for duration of study)
- Weight loss medications or procedures
- Current participation in another intervention study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 6-mo HiProt
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.
|
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).
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.
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.
|
Active Comparator: RecProt
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.
|
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).
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.
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.
|
Active Comparator: 18-mo HiProt
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. |
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).
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 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.
|
Change from Baseline to Month 18
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 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.
|
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
Time Frame: 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.
|
Change from Baseline to Month 18
|
6-month Change From Baseline in Femoral Bone Strength in kN
Time Frame: 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.
|
Change from Baseline to Month 6
|
18-month Change From Baseline in Femoral Bone Strength in kN
Time Frame: 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.
|
Change from Baseline to Month 18
|
18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
Time Frame: 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.
|
Change from Baseline to Month 18
|
6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
Change from Baseline to Month 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ashley Weaver, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00038668-A
- IRB00038668 (Other Identifier: Wake Forest University IRB)
- K25AG058804 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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