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RecruitingNCT06845046Updated Jun 26, 2026

A Study to Improve Skeletal Muscle in Veterans With HIV

An interventional study of w-3 fatty acid and L-carnitine in HIV and Obesity, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to male participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Male
01

Study 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.

Read the detailed description

The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. With the advances achieved in antiretroviral therapy (ART), Veterans with HIV now survive decades. However, this success is tempered by the rising burden of obesity now affecting 78% of Veterans. Defects in adipose tissue lipid storage and regulation are hallmarks of both treated HIV and obesity, which leads to a high degree of ectopic fat infiltrating organs and tissues such as skeletal muscle. 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". Further, the investigators found that high ectopic fat accumulation in muscle (quantified by CT imaging of skeletal muscle density) is associated with reduced mitochondrial oxidative capacity, greater inflammation, and impaired muscle glucose tolerance and insulin sensitivity. Hence the quality of muscle is just as important as the quantity of muscle. However, this important phenomenon has received little attention, especially in Veterans with HIV. Indeed, the need to target mobilizing and metabolizing skeletal muscle ectopic fat while preserving/increasing the total amount of skeletal muscle is most often overlooked and represents a major research gap and unmet clinical need. From the investigators current Merit Award funded study, the investigators have an established collaboration of experienced VA researchers with expertise in HIV and immunology, human nutrition and metabolism, endocrinology, radiology and imaging science, and muscle physiology. 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. This evidence-based intervention is designed to: a) increase lipid flux by facilitating the transfer of long-chain fatty acids into muscle mitochondria for -oxidation; b) decrease muscle proteolysis; and c) lessen insulin resistance and inflammation. Using a mixed 2x4 factorial design trial design in a cohort of 60 Veterans who have HIV and obesity, this study will determine the main and interaction effects of the multi-pronged intervention on: skeletal muscle density, mitochondrial oxidative capacity, and fatty acid oxidation (Aim 1); glucose tolerance, insulin sensitivity, and inflammation (Aim 2); and cardiopulmonary exercise tolerance and physical function (Aim 3). Obesity in Veterans with treated HIV is a heterogeneous condition. The investigators current Merit research shows myosteatotic obesity is a distinct condition from visceral or steatotic or sarcopenic obesity, affected by different clinical factors. The investigators findings to date provide the foundation for a novel evidence-based intervention that has the potential for significant clinical impact on Veterans, including and beyond those with HIV. This proposal meets VA-ORD priorities to improve health behaviors, focus on underserved Veterans, and provide precision care.

02

Conditions studied

  • HIV
  • Obesity

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Keywords

  • HIV
  • obesity
  • skeletal muscle
  • dietary supplement
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Placebo comparator
    Control Diet

    Diet high in unsaturated fat

    Other: Control Diet

  • Experimental
    Diet + w-3 fatty acids

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

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

  • Experimental
    Diet + L-Carnitine

    Diet high in unsaturated fat plus L-carnitine supplement

    Dietary Supplement: L-carnitine · Other: Control Diet

  • Experimental
    Diet + w-3 fatty acids + L-carnitine

    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

  • Dietary supplementw-3 fatty acid

    omega-3 fatty acid supplement

  • Dietary supplementL-carnitine

    L-carnitine supplement

  • OtherControl Diet

    Control Diet high in unsaturated fat

06

What researchers measure

Primary outcomes

  1. Myosteatosis

    CT quantified abdominal skeletal muscle density

    Time frame: Week 24 and 44

  2. MixedMeal GTT

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

    Time frame: Week 24 and 44

  3. Physical Function

    Physical Function Testing using Hand Grip Strength Dynamometer

    Time frame: Week 24 and 44

07

Study locations

1 of 1 sites recruiting
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
    Nashville, Tennessee 37212-2637, United States
    • Patrick M Lynch · Contact · Patrick.Lynch2@va.gov · (615) 873-6927
    • Geraldine M Freddie · Contact · Geraldine.Freddie@va.gov · (615) 873-8694
    • Heidi J Silver, PhD · Principal investigator
    • John R Koethe, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06845046
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Feb 25, 2025
Start date
Jul 15, 2025
Primary completion
Mar 30, 2029 (estimated)
Completion
Mar 30, 2029 (estimated)
Last update
Jun 26, 2026

Study contacts

Heidi J Silver, PhD
Contact
heidi.j.silver@vumc.org
(615) 875-9355
John R Koethe, MD
Contact
john.koethe@va.gov
(615) 873-6188
Heidi J Silver, PhD
principal investigator · Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
John R Koethe, MD
principal investigator · Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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