Recruiting

Dietary & Exercise

Sponsor:

VA Office of Research and Development

Code:

NCT06845046

Conditions

HIV

Obesity

Eligibility Criteria

Sex: Male

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

w-3 fatty acid

L-carnitine

Control Diet

Study Details

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.

Conditions

HIV

Obesity

Study ID

NCT06845046

Start date

Jul 15, 2025

Status verified date

Jun, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

w-3 fatty acid

omega-3 fatty acid supplement

L-carnitine

L-carnitine supplement

Control Diet

Control Diet high in unsaturated fat

Primary outcome measure

  • Myosteatosis [ Time Frame: Week 24 and 44 ]
  • MixedMeal GTT [ Time Frame: Week 24 and 44 ]
  • Physical Function [ Time Frame: Week 24 and 44 ]

Central Contacts and Locations

Central contacts

Heidi J Silver, PhD

(615) 875-9355heidi.j.silver@vumc.org

John R Koethe, MD

(615) 873-6188john.koethe@va.gov

Locations

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Recruiting

Nashville, Tennessee, United States, 37212-2637

Contacts

Patrick M Lynch

(615) 873-6927Patrick.Lynch2@va.gov

Geraldine M Freddie

(615) 873-8694Geraldine.Freddie@va.gov

Principal Investigator:

Heidi J Silver, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • HIV
  • obesity
  • skeletal muscle
  • dietary supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-26.