A Study to Improve Skeletal Muscle in Veterans With HIV

NCT06845046 | Recruiting DMC

• 1 other identifier: INFA-009-24F
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; obesity; skeletal muscle; dietary supplement

Outcome Measures

Primary Outcomes (3)

• Myosteatosis

  CT quantified abdominal skeletal muscle density

  Week 24 and 44

• MixedMeal GTT

  IV Glucose tolerance testing after consumption of BOOST as a meal substitute

  Week 24 and 44

• Physical Function

  Physical Function Testing using Hand Grip Strength Dynamometer

  Week 24 and 44

Study Arms (4)

Control Diet

PLACEBO COMPARATOR

Diet high in unsaturated fat

Other: Control Diet

Diet + w-3 fatty acids

EXPERIMENTAL

Diet high in unsaturated fat plus omega-3 fatty acid supplement

Dietary Supplement: w-3 fatty acid; Other: Control Diet

Diet + L-Carnitine

EXPERIMENTAL

Diet high in unsaturated fat plus L-carnitine supplement

Dietary Supplement: L-carnitine; Other: Control Diet

Diet + w-3 fatty acids + L-carnitine

EXPERIMENTAL

Diet high in unsaturated fat plus omega-3 fatty acid supplement plus L-carnitine supplement

Dietary Supplement: w-3 fatty acid; Dietary Supplement: L-carnitine; Other: Control Diet

Interventions

w-3 fatty acid DIETARY_SUPPLEMENT

omega-3 fatty acid supplement

Diet + w-3 fatty acids; Diet + w-3 fatty acids + L-carnitine

L-carnitine DIETARY_SUPPLEMENT

L-carnitine supplement

Diet + L-Carnitine; Diet + w-3 fatty acids + L-carnitine

Control Diet OTHER

Control Diet high in unsaturated fat

Control Diet; Diet + L-Carnitine; Diet + w-3 fatty acids; Diet + w-3 fatty acids + L-carnitine

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Heidi J Silver, PhD

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

• John R Koethe, MD

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi J Silver, PhD

CONTACT

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

John R Koethe, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: PI blinded to randomization group
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomization to one of 4 groups: Diet control group, Diet + w-3 supplement, Diet + L-carnitine supplement, Diet + w-3 + l-carnitine, followed by addition of resistance exercise training in each group, total intervention period is 4 weeks

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)