Amino Acid Intake for FSHD
(FSHD Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McGill University

No Placebo Group

Trial Summary

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

My condition is genetically confirmed as FSHD.

I've kept my diet, lifestyle, and weight stable for the last 3 months.

I am between 26 and 55 years old.

+2 more

Exclusion Criteria

My kidney function is impaired with high creatinine levels.

I am currently pregnant or breastfeeding.

I have used corticosteroids recently or for more than a year in the past.

+11 more

Participant Groups

The study aims to measure the daily protein needs of individuals with FSHD using a non-invasive method called the Indicator Amino Acid Oxidation (IAAO) technique, which could lead to improved dietary recommendations.

1Treatment groups

Experimental Treatment

Group I: Individuals with FSHDExperimental Treatment1 Intervention

Participants are to be randomly assigned varying levels of amino acid intakes ranging between 0.2 to 2.8 g/kg/d.