NCT06845046Recruiting
A Study to Improve Skeletal Muscle in Veterans With HIV
A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. The condition of excess lipid within and around muscle, termed myosteatosis, predisposes Veterans to physical function decline, frailty, disability, and cardiometabolic diseases such as diabetes and cardiovascular disease. In the investigators current Merit supported cohort, the investigators found that 36% of Veterans with treated HIV and obesity have "myosteatotic type obesity". Based on the investigators findings, the investigators have designed a multipronged integrated intervention that combines: 1) dietary replacement of saturated with unsaturated fats; 2) administration of L-carnitine and omega-3 fatty acid supplementation; and 3) targeted resistance exercise training.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- VA Office of Research and Development
- NCT number
- NCT06845046
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 15 Jul 2025 to the primary completion date, 30 Mar 2029
- 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.
Other illness
- diagnosed mitochondrial disorder
- diagnosed type 1 or type 2 diabetes
- use of metformin or other anti-diabetic agents for pre-diabetes
- inflammatory conditions or chronic corticosteroid use
- stage 3 or greater kidney disease
Lab values
- hemoglobin A1c of \>6.5% at screening visit
Other
- unstable body weight (gain or loss \> 5% over past 3 months)
- dietary or herbal supplements known to affect body weight, muscle mass, or immune function
- MRI incompatibility
- inability to perform physical function tests due to anatomical limitations
- contradictions to CPET such as exercise-induced ischemia or supplemental oxygen
Who the study is looking for
- Veteran
- HIV+
- antiretroviral therapy = integrase strand transfer inhibitor for at least 3 months
- HIV-1 RNA \<50 copies/ml
- age = 20 yrs
- BMI 28-50 kg/m2
Age in the registry: 20 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.