Clinical trial

A Study to Improve Skeletal Muscle in Veterans With HIV

Recruiting now · Not applicable · 1 countries · Registry ID NCT06845046

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 80 Years

SexMale

Healthy volunteersNot accepted

ConditionHIV, Obesity

Full registry 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

Treatments and study arms

w-3 fatty acid

Dietary Supplement

omega-3 fatty acid supplement

L-carnitine

Dietary Supplement

L-carnitine supplement

Control Diet

Other

Control Diet high in unsaturated fat

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN🇺🇸 Nashville, Tennessee, United States

Open map

Patrick M LynchContact

Email · Call (615) 873-6927

Geraldine M FreddieContact

Email · Call (615) 873-8694

Heidi J Silver, PhDPrincipal Investigator