Actively Recruiting
Dietary Protein Requirements in Adults With Facioscapulohumeral Muscular Dystrophy
Led by McGill University · Updated on 2026-02-06
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Facioscapulohumeral muscular dystrophy (FSHD) is a common type of muscular dystrophy affecting about 4 in 100,000 people. It causes progressive muscle loss, especially in the face, shoulders, and upper arms, leading to weaker muscles and reduced physical ability. Currently, there is no cure for FSHD, so treatments focus on easing symptoms. This trial aims to measure protein needs in adults with FSHD to help support muscle strength and function, using an advanced, non-invasive technique called indicator amino acid oxidation (IAAO). Participants in this study will be randomly assigned to consume different levels of amino acids ranging from 0.2 to 2.8 grams per kilogram of body weight per day. This dietary supplement approach is designed to assess how varying protein intake affects muscle protein synthesis in adults with FSHD. The study will take place over seven weeks, during which protein requirements will be measured using the IAAO method. During the study, participants will undergo assessments of protein metabolism, including measuring 13CO2 excretion and L-[13C]-Phenylalanine oxidation. Participants must maintain stable medication, supplement use, diet, lifestyle habits, and body weight during the trial. The researchers will monitor these factors alongside the protein metabolism measurements to better understand the dietary protein needs in FSHD. The total study duration is seven weeks, with careful monitoring to ensure participant safety and adherence.
CONDITIONS
Brief Title
Dietary Protein Requirements in Adults With Facioscapulohumeral Muscular Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 b2-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 64 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 65 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 weeks
Participants receive varying levels of amino acid intakes ranging between 0.2 to 2.8 g/kg/day to study dietary protein requirements.
Trial Site Locations
Total: 2 locations
1
McGill university
Montreal, Quebec, Canada, H2W 1S4
Actively Recruiting
2
McGill university
Montreal, Quebec, Canada, H3A 0G4
Not Yet Recruiting
Research Team
T
Tyler A Churchward-Venne, Ph.D.
A
Arianne Zabbal, B.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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