Understanding protein needs in adults with facioscapulohumeral muscular dystrophy
Dietary Protein Requirements in Adults With Facioscapulohumeral Muscular Dystrophy
This study is testing how much protein adults with facioscapulohumeral muscular dystrophy need to help maintain their muscle health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 26 Years to 60 Years |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06785428 on ClinicalTrials.gov |
What this trial studies
This study investigates the dietary protein requirements of adults diagnosed with facioscapulohumeral muscular dystrophy (FSHD), a condition characterized by progressive muscle loss. The research aims to determine the optimal protein intake necessary to support muscle maintenance and overall health in affected individuals. Participants will be adults aged 26 to 60 who have been genetically confirmed to have FSHD and have stable dietary habits. The study will utilize the indicator amino acid oxidation technique to assess protein needs and guide dietary recommendations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 26 to 60 with genetically confirmed facioscapulohumeral muscular dystrophy who are ambulatory and have stable health conditions.
Not a fit: Patients who are pregnant or lactating, or those who have recently used corticosteroids or certain other medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored dietary guidelines to help maintain muscle mass and improve quality of life for patients with FSHD.
How similar studies have performed: While there is limited research specifically targeting protein requirements in FSHD, studies on dietary interventions in muscular dystrophies have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec and 1 other locations
- McGill university — Montreal, Quebec, Canada (Recruiting)
- McGill university — Montreal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Tyler A Churchward-Venne, Ph.D.
- Email: tyler.churchward-venne@mcgill.ca
- Phone: (514) 398-4184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.