NCT06845046 A Study to Improve Skeletal Muscle in Veterans With HIV
| NCT ID | NCT06845046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-07-15 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Heidi J Silver, PhD
PRINCIPAL INVESTIGATOR
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Frequently Asked Questions
Who can join the NCT06845046 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 80 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845046 currently recruiting?
Yes, NCT06845046 is actively recruiting participants. Contact the research team at heidi.j.silver@vumc.org for enrollment information.
Where is the NCT06845046 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06845046 clinical trial?
NCT06845046 is sponsored by VA Office of Research and Development. The principal investigator is Heidi J Silver, PhD at Tennessee Valley Healthcare System Nashville Campus, Nashville, TN. The trial plans to enroll 70 participants.
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