N/A
N=187
Utilizing Protein During Weight Loss to Impact Physical Function and Bone
Obesity · Weight Loss · Diet Modification · Aging · Weight Change, Body
Bottom Line
View on ClinicalTrials.gov: NCT03819478 ↗Enrolled (actual)
187
Serious AEs
9.6%
Results posted
Jan 2024
Primary outcome: Primary: 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 — -0.91; -1.77; -0.03 mg/cm^3 — p=0.4880
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight loss intervention months 0-6 (Behavioral); Exercise intervention months 0-6 (Behavioral); NutraBio™ CarboMax Supplement (Dietary_supplement); 6-month NutraBio™ 100% Whey Protein Isolate Supplement (Dietary_supplement); 18-month NutraBio™ 100% Whey Protein Isolate Supplement (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 |
-0.91; -1.77; -0.03 | 0.4880 |
| 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 |
7.42; 6.45 | 0.7636 |
| 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 |
-0.20; -9.96; -5.17 | 0.1584 |
| SECONDARY 6-month Change From Baseline in Femoral Bone Strength in kN |
-0.02; 0.10 | 0.0350 sig |
| SECONDARY 18-month Change From Baseline in Femoral Bone Strength in kN |
-0.02; 0.03; 0.09 | 0.2422 |
| SECONDARY 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm |
0.02; 0.02; 0.01 | 0.5119 |
| SECONDARY 6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm |
0.01; 0.01 | 0.8500 |
| 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 |
-1.40; -0.39; -2.59 | 0.3685 |
| 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 |
2.87; 3.56 | 0.5334 |
| SECONDARY 6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 |
0.34; 1.59 | 0.1573 |
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.
Eligibility 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 - 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 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 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
Data sourced from ClinicalTrials.gov (NCT03819478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.