RecruitingNot ApplicableNCT06845046

A Study to Improve Skeletal Muscle in Veterans With HIV

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

Sponsor

VA Office of Research and Development

Enrollment

70 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity HIV

Summary

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.

Eligibility

Sex: MALEMin Age: 20 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria11

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