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NCT03835416 · ClinicalTrials.gov registry record · NA
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
NCT03835416: Completed NA study, sponsored by VA Office of Research and Development.
NCT03835416 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 105 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835416, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
Study Summary
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".
Primary Outcome
SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning.
Interventions
- DIETARY_SUPPLEMENT Foods rich in high quality protein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
What the finished NCT03835416 record still lists
NCT03835416 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Foods rich in high quality protein is the first listed.
NCT03835416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03835416 about?
NCT03835416 is a clinical study titled "Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein". 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-prot...
What is the current status of trial NCT03835416?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2019-12-12. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT03835416?
The interventions under investigation include: Foods rich in high quality protein (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03835416?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03835416's enrollment target sits among peer trials
105 834th of 2000 higher than 1,165 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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