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HIVNCT06845046

A Study to Improve Skeletal Muscle in Veterans With HIV

A study testing w-3 fatty acid and L-carnitine in people with HIV and Obesity, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years, men only
Conditions the study is for
HIV, Obesity
What is being tested?
w-3 fatty acid and L-carnitine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to 30 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    Nashville, Tennessee, 37212-2637

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

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

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV

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.

Conditions
HIV, Obesity
Being tested
w-3 fatty acid, L-carnitine, Control Diet
Keywords
HIV, obesity, skeletal muscle, dietary supplement
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • w-3 fatty acidDietary supplement

    omega-3 fatty acid supplement

  • L-carnitineDietary supplement

    L-carnitine supplement

  • Control DietOther

    Control Diet high in unsaturated fat

Study groups in NCT06845046
Study groupRoleWhat they receive
Control DietPlacebo comparatorDiet high in unsaturated fat
Receives: Other: Control Diet
Diet + w-3 fatty acidsExperimentalDiet high in unsaturated fat plus omega-3 fatty acid supplement
Receives: Dietary Supplement: w-3 fatty acid; Other: Control Diet
Diet + L-CarnitineExperimentalDiet high in unsaturated fat plus L-carnitine supplement
Receives: Dietary Supplement: L-carnitine; Other: Control Diet
Diet + w-3 fatty acids + L-carnitineExperimentalDiet high in unsaturated fat plus omega-3 fatty acid supplement plus L-carnitine supplement
Receives: Dietary Supplement: w-3 fatty acid; Dietary Supplement: L-carnitine; Other: Control Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myosteatosis

    CT quantified abdominal skeletal muscle density

    Measured: Week 24 and 44

  2. MixedMeal GTT

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

    Measured: Week 24 and 44

  3. Physical Function

    Physical Function Testing using Hand Grip Strength Dynamometer

    Measured: Week 24 and 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start15 Jul 2025
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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
Masking
Single blind
Who is masked
Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845046
Sponsor's protocol ID
INFA-009-24F
Status last verified
Jun 2026
First submitted
19 Feb 2025
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing w-3 fatty acid and L-carnitine in people with HIV and Obesity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heidi J Silver, PhD ((615) 875-9355, heidi.j.silver@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myosteatosis (time frame: Week 24 and 44). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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