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A Study to Improve Skeletal Muscle in Veterans With HIV

RecruitingNAAges 20 Years - 80 YearsMaleVA Office of Research and Development
NCT06845046 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • w-3 fatty acid
  • L-carnitine
  • Control Diet
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Where

1 site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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