Home › Obesity › NCT06845046
A Study to Improve Skeletal Muscle in Veterans With HIV
A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV
Who can join
Ages 20 to 80 · Men
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * unstable body weight (gain or loss \> 5% over past 3 months) * diagnosed mitochondrial disorder * diagnosed type 1 or type 2 diabetes * use of metformin or other anti-diabetic agents for pre-diabetes * hemoglobin A1c of \>6.5% at screening visit * inflammatory conditions or chronic corticosteroid use * stage 3 or greater kidney disease * 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
About the study
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.
What is being tested
- w-3 fatty acid (dietary supplement)
- L-carnitine (dietary supplement)
- Control Diet (other)
Sponsor: VA Office of Research and Development · Participants: 70 · Started: Jul 15, 2025
Contact the study team
- Heidi J Silver, PhD · Phone: (615) 875-9355
- John R Koethe, MD · Phone: (615) 873-6188
Official record on ClinicalTrials.gov — NCT06845046
Locations in the U.S.
| Tennessee | Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.