A Study to Improve Skeletal Muscle in Veterans With HIV

Recruiting now · Not applicable

Conditions studied: HIV, Obesity

In brief

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.

Key facts

Study ID

NCT06845046

Run by

VA Office of Research and Development

People needed

70

Starts

2025-07-15

Expected to finish

2029-03-30

Last updated by the study team

2026-06-26

Who can join

Age: 20 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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