Improving skeletal muscle in Veterans with HIV

A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV

This will test whether switching saturated fats to unsaturated fats, giving L‑carnitine and omega‑3 supplements, and adding targeted resistance exercise can reduce fat in muscle and improve muscle health in Veterans with HIV and obesity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 20 Years to 80 Years
• Sex: Male
• Sponsor: VA Office of Research and Development (fed)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06845046 on ClinicalTrials.gov

What this trial studies

The trial enrolls Veterans living with HIV who are virally suppressed on integrase‑based ART and have obesity, and delivers a multipronged intervention combining dietary fat replacement (less saturated, more unsaturated fats), L‑carnitine plus omega‑3 supplementation, and targeted resistance exercise training compared with a control diet. Outcomes include changes in muscle fat infiltration measured by CT (muscle density), mitochondrial oxidative capacity, inflammation markers, muscle glucose handling, and physical function. Participants with contraindications such as diabetes, unstable weight, significant kidney disease, or MRI/CPET incompatibility are excluded. The aim is to mobilize and metabolize ectopic muscle fat while preserving or increasing muscle mass to reduce frailty and cardiometabolic risk in this population.

Who should consider this trial

Good fit: Ideal candidates are Veterans living with HIV who are on an integrase strand transfer inhibitor with HIV‑1 RNA <50 copies/mL, aged 20 or older, and with a BMI of 28–50 kg/m2.

Not a fit: People with diagnosed diabetes, unstable recent weight change, diagnosed mitochondrial disorders, stage 3+ kidney disease, or who cannot do the exercise testing/training are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could reduce harmful fat in and around muscle, improve strength and physical function, and lower cardiometabolic risk for Veterans with HIV and obesity.

How similar studies have performed: Individual components such as omega‑3s, L‑carnitine, dietary fat modification, and resistance training have shown metabolic or muscle benefits in other populations, but combining them specifically to target myosteatosis in Veterans with treated HIV is a novel, largely untested approach.

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

Where this trial is running

Nashville, Tennessee

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

Study contacts

• Principal investigator: Heidi J Silver, PhD — Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
• Study coordinator: Heidi J Silver, PhD

Conditions: HIV, Obesity, obesity, skeletal muscle, dietary supplement