NCT03835416Completed
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the VA mission to "maximize the physical and social autonomy of Veterans".
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 29 Jan 2019
- Start date
- 12 Dec 2019
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Obesity
- NCT number
- NCT03835416
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From 12 Dec 2019 to the primary completion date, 26 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindicated medications, including narcotic mail-outs and active substance abuse
Other illness
- Presence of unstable or symptomatic life-threatening illness
- Neurological conditions causing functional impairments, including:
- Parkinson's Disease
- multiple sclerosis
- permanent disability due to stroke
- History of significant weight instability
- Any psychiatric condition that would prevent the subject from participating in a group intervention setting, including diagnosed personality disorders
Lab values
- Glomerular filtration rates (GFR) less than 45 mL/min
- A GFR of 45-59 requires bi-monthly testing per the investigators' established algorithm
- Those with a GFR \<45 mL/min are excluded
Other
- Mini Cog score of \<3
- --Vegetarian
- Inability to complete physical function assessment
- Primary care provider disapproves participation
Who the study is looking for
- Male Veterans
- African American or Caucasian
- Obese (BMI \> 30 kg/m2)
- Age 55+ years
- Pre-diabetes (confirmed fasting plasma glucose 100 and \<126 mg/dL) or HbA1c 5.7-6.4%
- Short Physical Performance Battery score of 4 to 11 units
- Age-normal renal function
- English speaking
- Able to record dietary intake or has a proxy who can record dietary intake
- Willing and able to be randomized to either intervention group
Age in the registry: 55 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Durham VA Medical Center, Durham, NC Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
- Influence of Protein Intake during Obesity Reduction on Physical Function and Body Habitus in Older Males with Prediabetes: A Pilot Study.Curr Dev Nutr · 2026 · PMID 42701496
This page is information, not medical advice. Discuss any trial with your doctor.