A Study to Improve Skeletal Muscle in Veterans With HIV

What Was Tested

The trial (not phased) is built around L-Carnitine.

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.

It had four arms (groups): Control Diet (placebo comparator), Diet + w-3 fatty acids (experimental), Diet + L-Carnitine (experimental) and Diet + w-3 fatty acids + L-carnitine (experimental).

Diet high in unsaturated fat.

Diet high in unsaturated fat plus omega-3 fatty acid supplement.

Diet high in unsaturated fat plus L-carnitine supplement.

The registry classes the interventions as dietary supplement and other.

More on the Plan

With the advances achieved in antiretroviral therapy (ART), Veterans with HIV now survive decades.

Defects in adipose tissue lipid storage and regulation are hallmarks of both treated HIV and obesity, which leads to a high degree of ectopic fat infiltrating organs and tissues such as skeletal muscle.

Hence the quality of muscle is just as important as the quantity of muscle.

However, this important phenomenon has received little attention, especially in Veterans with HIV.

Who Took Part

70 planned participants were the target.

It was open to men only aged from 20 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: diagnosed mitochondrial disorder; diagnosed type 1 or type 2 diabetes; use of metformin or other anti-diabetic agents for pre-diabetes.

How the Study Was Run

Design: randomized, factorial and single-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

In this single-blind L-Carnitine study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2025-07-15 with completion listed for 2029-03-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Myosteatosis (time frame: Week 24 and 44). MixedMeal GTT (time frame: Week 24 and 44). Physical Function (time frame: Week 24 and 44).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 70 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.