How much protein do FSHD patients really need? new study aims to find out
NCT ID NCT06785428
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
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10 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Apr 2026
- Lead sponsor
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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
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26 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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McGill university
Montreal, Quebec, H2W 1S4, Canada
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McGill university
Montreal, Quebec, H3A 0G4, Canada
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