N/A
N=187
Utilizing Protein During Weight Loss to Impact Physical Function
Obesity · Weight Loss · Diet Modification · Aging · Weight Change, Body
Bottom Line
View on ClinicalTrials.gov: NCT03074643 ↗Enrolled (actual)
187
Serious AEs
9.6%
Results posted
May 2023
Primary outcome: Primary: Change in Expanded Short Physical Performance Battery Score — 0.06; 0.11; 0.16 score on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight loss intervention months 0-6 (Behavioral); Exercise intervention months 0-6 (Behavioral); Carbohydrate supplement for months 0-6 (Dietary_supplement); Protein supplement for months 0-6 (Dietary_supplement); Protein supplement for follow-up months 7-18 (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 Change in Expanded Short Physical Performance Battery Score |
0.06; 0.11; 0.16 | 0.16 |
| SECONDARY Lower Extremity Muscle Strength |
8.28; 6.27; 7.30 | 0.81 |
| SECONDARY Weight Change |
-2.67; -3.23; -3.28 | 0.56 |
| SECONDARY Total Body Lean Mass |
-1.24; -1.68; -1.36 | 0.76 |
| SECONDARY Total Body Fat Mass |
-1.47; -1.68; -1.72 | 0.75 |
| SECONDARY Thigh Muscle Volume |
-3.76; -5.40; -8.42 | 0.06 |
| SECONDARY Intermuscular Adipose Tissue |
0.72; 0.44; 1.11 | 0.48 |
Summary
This study will 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 physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Eligibility Criteria
Inclusion Criteria
- 65-85 years
- BMI: 27-45 kg/m2
- No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
- eSPPB 160/90 mmHg);
- Insulin-dependent or uncontrolled diabetes (HbA1c ≥8%)
- 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 (eGFR 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, or protein supplements
- Weight loss medications or procedures
- Current participation in another intervention study
Data sourced from ClinicalTrials.gov (NCT03074643). 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.