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Could a common supplement slow ALS? duke launches pilot trial

NCT ID NCT07589764

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This early-stage trial tests whether a daily supplement called HMB (beta-hydroxy-beta-methylbutyrate) is safe and can lower certain blood markers linked to ALS. One hundred adults with ALS will take 3 grams of HMB daily. Researchers will track changes in blood markers and functional abilities over time. The goal is to see if HMB might slow disease progression.

What this could mean

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

Active substance
beta-hydroxy-beta-methylbutyrate (HMB) supplement
What this could lead to
If it works, this could point toward a simple supplement to slow ALS progression and improve quality of life.
What could go wrong
This is a very early Phase 1 pilot trial with only 100 people, no placebo group, and it measures a biomarker (IGFBP7) that may not directly translate to clinical benefit. The supplement may not slow the disease.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

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: 1. Male or female aged at least 18 years. 2. Sporadic or familial ALS diagnosed as per Gold Coast Criteria (37). 3. Patient is able to understand and express informed consent (in the opinion of the site investigator). 4. Patient is able to read and write English. 5. Patient is expected to survive for the duration of the trial. 6. Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal) 7. Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method. Exclusion Criteria: 1. Actively or recently (within past 30 days) participating in another intervention trial. 2. Currently or recently (within 30 days) taking HMB 3. Prior side effects from HMB deemed to be significant by the investigator 4. Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study. 5. Pregnant women or women currently breastfeeding. 6. Elevated serum calcium or vitamin D levels. 7. Life expectancy shorter than the duration of the trial.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

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

Amyotrophic lateral sclerosis (ALS)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

    Contact Email: •••••@•••••

  • Temple University

    Philadelphia, Pennsylvania, 19122, United States

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