How much protein do FSHD patients really need? new study aims to find out

NCT ID NCT06785428

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study looks at how much protein adults with facioscapulohumeral muscular dystrophy (FSHD) need each day to support muscle health. Researchers will test different amino acid intakes in 10 participants using a non-invasive technique. The goal is to improve dietary recommendations for people with FSHD, who often have progressive muscle loss.

What this could mean

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

Active substance
Amino acid intake (dietary supplement)
What this could lead to
If successful, this could lead to better dietary protein recommendations for people with FSHD, helping them maintain muscle strength and function.
What could go wrong
This is a small, early-stage study with only 10 participants, so results may not apply to everyone with FSHD. It measures protein needs, not a treatment or cure.

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

10 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

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

26 to 60 years

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: * Adult female or male participants who are 26 to 60 years of age at screening (inclusive) * Genetically confirmed with FSHD * Ambulatory * Has maintained stable use of medication and supplements, stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study * Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures Exclusion Criteria: * Individuals who are lactating or pregnant * Usage of corticosteroids within 3 months of study entry or had ever taken steroids for a duration exceeding 1 year * On androgens or growth hormone within 6 months before screening and for duration of study; topical physiologic androgen replacement is permitted * On sympathomimetic agents, antidepressants, or β-receptor blockers * Have cardiovascular disease * Evidence of an alternative diagnosis other than FSHD or a coexisting myopathy or dystrophy * Current/active malignancy (e.g., remission less than 5 years' duration), with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin * Type 1 or type 2 diabetes mellitus * History of sensitivity to protein pharmaceuticals * Known active substance abuse, including alcohol * Renal impairment (serum creatinine ≥ 2 times the upper limit of normal,(ULN)) * History of severe restrictive or obstructive lung disease, or evidence for interstitial lung disease on screening chest radiograph * Major surgery within 4 weeks prior to metabolic trial 1 * Any other active or unstable medical/psychological conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • McGill university

    Montreal, Quebec, H2W 1S4, Canada

  • McGill university

    Montreal, Quebec, H3A 0G4, Canada

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