Actively Recruiting
A Study to Improve Skeletal Muscle in Veterans With HIV
Led by VA Office of Research and Development · Updated on 2025-07-30
70
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study to Improve Skeletal Muscle in Veterans With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran
- HIV positive
- On integrase strand transfer inhibitor antiretroviral therapy for at least 3 months
- HIV-1 RNA less than 50 copies/ml
- Age 20 to 80 years
- Body mass index (BMI) between 28 and 50 kg/m2
You will not qualify if you...
- Unstable body weight with more than 5% gain or loss in past 3 months
- Diagnosed mitochondrial disorder
- Diagnosed type 1 or type 2 diabetes
- Use of metformin or other anti-diabetic drugs for pre-diabetes
- Hemoglobin A1c greater than 6.5% at screening
- Inflammatory conditions or chronic corticosteroid use
- Stage 3 or higher kidney disease
- Use of dietary or herbal supplements affecting body weight, muscle mass, or immune function
- MRI incompatibility
- Inability to perform physical function tests due to anatomical limitations
- Contraindications to cardiopulmonary exercise testing such as exercise-induced ischemia or need for supplemental oxygen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Actively Recruiting
Research Team
H
Heidi J Silver, PhD
CONTACT
J
John R Koethe, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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