Amino Acid Intake for FSHD

(FSHD Trial)

Recruiting at 1 trial location

Overseen By Arianne Zabbal, B.Sc.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Must not be taking: Corticosteroids, Androgens, Antidepressants, others

Disqualifiers: Cardiovascular disease, Diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the protein requirements for maintaining muscle strength and function in individuals with Facioscapulohumeral muscular dystrophy (FSHD). Researchers will use a non-invasive method to assess protein needs, as current guidelines may not suffice for those with FSHD. Participants will receive varying amounts of amino acids, the building blocks of protein, to identify the most effective dosage. Individuals with FSHD who can walk and have maintained a stable lifestyle for three months may qualify for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could redefine nutritional guidelines for FSHD.

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 prior data suggests that this method is safe for individuals with FSHD?

Research shows that amino acids are generally safe and support muscle health. As the building blocks of protein, amino acids are essential for maintaining strong muscles. Studies have found that adequate protein intake is crucial for muscle maintenance, especially in conditions like facioscapulohumeral muscular dystrophy (FSHD), which causes muscle loss.

Although specific guidelines for protein consumption in FSHD patients are lacking, it is clear they require sufficient protein. No evidence indicates negative effects from increased amino acid intake in these patients. Ongoing research aims to determine the optimal protein amount for FSHD, but current evidence suggests amino acids are safe for most people.

Since this trial is not in its early stages, there is already some confidence in the safety of amino acid intake. However, further research will help establish the best amounts needed to support muscles in FSHD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Facioscapulohumeral Muscular Dystrophy (FSHD) focus on managing symptoms through physical therapy, pain management, and sometimes surgical interventions. However, the intake of amino acids targets muscle health directly by providing essential building blocks for muscle repair and growth. Researchers are excited about this treatment because it offers a nutritional approach that could support muscle function and potentially slow disease progression. This method is unique as it leverages the body's natural processes to potentially improve muscle strength and endurance in individuals with FSHD, offering a promising alternative or complement to existing therapies.

What evidence suggests that amino acid intake might be an effective treatment for FSHD?

Research has shown that amino acids, the building blocks of protein, can help maintain muscles. For individuals with conditions causing muscle loss, amino acids have proven beneficial, although data specifically for FSHD (Facioscapulohumeral Muscular Dystrophy) remains limited. People with FSHD often struggle to build muscle, but improving protein intake might help. Studies suggest that the current recommended protein amount might be too low, and increasing it could help maintain muscle strength and function. In this trial, participants with FSHD will receive varying levels of amino acid intake, ranging from 0.2 to 2.8 g/kg/d. Researchers are using a non-invasive method called the indicator amino acid oxidation technique to better understand the protein needs of people with FSHD. This could lead to more accurate dietary advice to support their muscle health. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amino Acid Intake

Trial Overview 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.

How Is the Trial Designed?

Group I: Individuals with FSHD Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

A comprehensive review of clinical studies has established the first tolerable upper intake levels (ULs) for several essential and nonessential amino acids, indicating that they are generally well tolerated in healthy adults.

Specific ULs were determined for amino acids such as leucine (35 g/d for young adults), tryptophan (4.5 g/d), and arginine (30 g/d), which can guide safety standards for amino acid supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerable Upper Intake Level for Individual Amino Acids in Humans: A Narrative Review of Recent Clinical Studies. Elango, R.[2023]

A study involving healthy young men showed that lower leucine intakes (7 or 14 mg/kg/d) led to negative nitrogen balance initially, indicating that the current recommended leucine requirement for adults may be too low.

The findings suggest that the actual leucine requirement is greater than 14 mg/kg/d, as participants on lower intakes had reduced protein synthesis and adaptation, while those on 30 mg/kg/d maintained better nitrogen balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leucine kinetics during three weeks at submaintenance-to-maintenance intakes of leucine in men: adaptation and accommodation. Young, VR., Gucalp, C., Rand, WM., et al.[2013]

The increasing use of amino acids from various sources necessitates thorough safety assessments due to the potential for high intake levels that exceed normal dietary amounts.

Establishing reliable Tolerable Upper Intake Levels (ULs) for amino acids is challenging due to insufficient toxicity studies and lack of clinical data, highlighting the need for comprehensive safety evaluations that include quality specifications and potential interactions with medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. Oketch-Rabah, HA., Roe, AL., Gurley, BJ., et al.[2023]

In critical illness, skeletal muscle undergoes adaptations that can lead to insulin resistance and muscle wasting, making adequate protein and amino acid nutrition essential for recovery, with optimal intake levels suggested to be between 1.3 and 1.5 g/kg/day.

Anabolic resistance in critically ill patients reduces the effectiveness of protein intake, highlighting the importance of mobility protocols in intensive care to enhance nutritional interventions and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein metabolism and requirements. Biolo, G.[2019]

The study established no observed adverse effect levels (NOAELs) for supplemental methionine (46 mg/kg/d), histidine (8.0 g/d), and lysine (6.0 g/d) in healthy adults, indicating these amounts are safe for consumption in fortified foods or dietary supplements.

These safety recommendations are crucial for regulatory and nutritional practices, as they guide the safe use of amino acids in various dietary contexts aimed at improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposals for Upper Limits of Safe Intake for Methionine, Histidine, and Lysine in Healthy Humans. Cynober, L., Bier, DM., Stover, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11944979/

State-of-the-Art and Future Challenges for Nutritional ... This review aims to investigate the potential role of dietary patterns and specific nutrients in modulating muscle metabolism within the context of FSHD.

2. withpower.com withpower.com/trial/amino-acid-intake-for-fshd-13cfc

Amino Acid Intake for FSHD (FSHD Trial) 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, ...

3. trialx.com trialx.com/clinical-trials/listings/296853/dietary-protein-requirements-in-adults-with-facioscapulohumeral-muscular-dystrophy/

Dietary Protein Requirements in Adults With ... Daily consumption of adequate amounts of dietary protein is essential to support muscle mass maintenance and overall health and function across ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000001808

Aerobic training and postexercise protein in ... This randomized, controlled study showed that regular endurance training improves fitness, walking speed, and self-assessed health in patients with FSHD ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0891584924001667

Effect of antioxidant supplementation Antioxidant supplementation significantly changed muscle and fat volumes in the non-dominant quadriceps, and muscle quality in the dominant quadriceps.

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.00755/full

Preliminary Evidences of Safety and Efficacy of Flavonoids ... A 24 weeks randomized double-blind placebo-controlled clinical study was aimed at evaluating the safety and efficacy of daily oral administration of flavonoids ...