A Study to Improve Skeletal Muscle in Veterans With HIV (NCT06845046) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Improve Skeletal Muscle in Veterans With HIV
United States70 participantsStarted 2025-07-15
Plain-language 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.
Who can participate
Age range
20 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.