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New study tests Muscle-Building combo for veterans with HIV and obesity

NCT ID NCT06845046

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of a special diet, omega-3 and L-carnitine supplements, and resistance exercise can improve muscle quality and reduce fat in veterans with HIV and obesity. The trial will enroll 70 participants and measure changes in muscle density, metabolism, and physical function. It aims to address a common condition called myosteatosis, which can lead to frailty and heart disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omega-3 fatty acid and L-carnitine supplements, plus a diet high in unsaturated fats and resistance exercise
What this could lead to
If successful, this could point toward a way to improve muscle health and reduce fat in people with HIV, potentially lowering their risk of frailty and heart disease.
What could go wrong
This is a small, early-stage trial with only 70 participants, so results may not apply to everyone. The combination of diet, supplements, and exercise may be hard to stick with long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    RECRUITING

    Nashville, Tennessee, 37212-2637, United States

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