A Study to Improve Skeletal Muscle in Veterans With HIV

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
VA Office of Research and Development
Study ID
NCT06845046
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Jun 29, 2029
Completion
Jun 29, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Diet
    Diet high in unsaturated fat
  • Experimental: Diet + w-3 fatty acids
    Diet high in unsaturated fat plus omega-3 fatty acid supplement
  • Experimental: Diet + L-Carnitine
    Diet high in unsaturated fat plus L-carnitine supplement
  • Experimental: Diet + w-3 fatty acids + L-carnitine
    Diet high in unsaturated fat plus omega-3 fatty acid supplement plus L-carnitine supplement

Primary Outcome Measure

Myosteatosis [ Time Frame: Week 24 and 44 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637
Patrick M Lynch
[email protected]
615-873-6927
Geraldine M Freddie
[email protected]
(615) 873-8694
Heidi J Silver, PhD (PRINCIPAL_INVESTIGATOR)
John R Koethe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
HIVObesity / overweight
By specialty
Infectious diseaseEndocrinologyMetabolic healthWeight loss
By research site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN· Nashville, TN

Related Studies