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Study to Improve Muscle Health in Veterans with HIV and Obesity

This study is for male Veterans aged 20-80 who have HIV, are on stable antiretroviral therapy, and have obesity. It aims to improve muscle health, specifically addressing a condition called myosteatosis (excess fat in and around muscles). Participants will receive either omega-3 fatty acid supplements, L-carnitine supplements, or a control diet high in unsaturated fat. The researchers will measure changes in myosteatosis, how your body processes sugar (MixedMeal GTT), and your physical function at 24 and 44 weeks to see if these interventions are successful. You cannot join if you have unstable weight, a mitochondrial disorder, or diabetes.

Study design
This interventional study plans to enroll 70 male Veterans. Participants will be assigned to one of three groups: omega-3 fatty acid, L-carnitine, or a control diet.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your myosteatosis, sugar processing, and physical function will be measured at 24 and 44 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06845046

A Study to Improve Skeletal Muscle in Veterans With HIV

Recruiting
NAAges 20–80InterventionalTreatment
VA Office of Research and Development
~70 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:w-3 fatty acidL-carnitineControl Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Myosteatosis
Measured over Week 24 and 44
+2 more outcomes measured

Conditions

HIV
Obesity

Explore related trials

HIV InfectionObesityHIV Infection

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Heidi J Silver, PhD · PRINCIPAL_INVESTIGATOR · Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • John R Koethe, MD · PRINCIPAL_INVESTIGATOR · Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Who to contact

Heidi J Silver, PhD
[email protected]
(615) 875-9355
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • MyosteatosisWeek 24 and 44

    CT quantified abdominal skeletal muscle density

  • MixedMeal GTTWeek 24 and 44

    IV Glucose tolerance testing after consumption of BOOST as a meal substitute

  • Physical FunctionWeek 24 and 44

    Physical Function Testing using Hand Grip Strength Dynamometer