Amino Acid Intake for FSHD
(FSHD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you maintain stable use of your current medications and supplements throughout the study, so you should not stop taking them.
What data supports the effectiveness of the treatment Amino Acid Intake for FSHD?
Research suggests that amino acids play a crucial role in supporting muscle health and recovery, especially in conditions involving muscle wasting. While specific data on FSHD (a muscle disorder) is not provided, amino acids have been shown to be beneficial in other conditions involving muscle loss, indicating potential effectiveness.12345
Is amino acid intake generally safe for humans?
How does amino acid intake differ from other treatments for FSHD?
Amino acid intake for FSHD is unique because it focuses on providing specific nutrients, like leucine, that may support muscle health and protein synthesis, unlike other treatments that might target symptoms or disease mechanisms directly. This approach is based on understanding how amino acids are metabolized and utilized in the body, which can be different from traditional drug therapies.1112131415
What is the purpose of this trial?
Facioscapulohumeral muscular dystrophy (FSHD) is one of the most common types of muscular dystrophy, affecting about 4 out of 100,000 individuals. The disease is characterized by progressive muscle loss (i.e., muscle atrophy) commonly affecting the face, shoulders, and upper arm muscles. The muscle loss ultimately results in reduced strength and impaired physical performance. At present there is no cure for FSHD, therefore, physicians have focused on therapeutic interventions to help alleviate these symptoms.Daily consumption of adequate amounts of dietary protein is essential to support muscle mass maintenance and overall health and function across the lifespan. However, previous research has reported inadequate protein intake in individuals with FSHD. The characteristic of progressive muscle loss in individuals with FSHD and other muscular dystrophies is ultimately due to an imbalance in the rate of muscle building (i.e., muscle protein synthesis) and muscle breakdown (i.e., muscle protein breakdown), where individuals with FSHD have been shown to have reduced rates of muscle building. As inadequate protein intake is known to result in a loss of muscle mass, strength and function, this loss may be amplified in individuals with FSHD.Dietary recommendations traditionally have been determined through nitrogen balance techniques, where the current recommended dietary allowance (RDA) for daily protein intake for adults is 0.8 g/kg/d. However, recent research indicates how the nitrogen balance technique potentially underestimates protein requirements. Therefore, there is a need to reassess current dietary recommendations in adults with FSHD in order to help support the maintenance of muscle strength and function.Recent efforts to understand protein requirements in various populations have been completed using the indicator amino acid oxidation technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. Due to its non-invasive nature, the IAAO method allows researchers to use this technique in individuals with FSHD, where there is currently limited work in studying this population.The purpose of this study is to measure the protein requirements in individuals with FSHD using the non-invasive IAAO technique.
Eligibility Criteria
This trial is for adults with Facioscapulohumeral Muscular Dystrophy (FSHD), a condition causing progressive muscle loss. Participants should have FSHD and be interested in how dietary protein affects their muscle health.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned varying levels of amino acid intakes ranging between 0.2 to 2.8 g/kg/d to measure protein requirements using the IAAO technique
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Amino Acid Intake
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University
Lead Sponsor