Amino Acids and Exercise in FSHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Pavia
About this trial
This study evaluates whether amino acid supplementation, combined with a structured diet and exercise program, improves body composition (increased muscle mass and reduced fat mass) and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses to the intervention between individuals with FSHD and healthy individuals matched for age and sex.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects of both sexes with a diagnosis of FSHD, confirmed by genetic testing.
Age between 18 and 50 years.
Belonging to clinical category A among the four defined in the Comprehensive Clinical Evaluation Form. These patients present the most characteristic signs of the disease: muscle weakness of the facial and scapular girdle.
Clinical score ranging from 2 to 5.
Disqualifiers
Use of beta-blocker medications;
Psychological or psychiatric disorders;
Musculoskeletal injuries that impair the ability to perform physical exercise;
Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);
Trial design
Design model
Crossover
Treatments tested in this trial
Essential Amino Acids Supplementation intervention
Dietary supplementUse of a balanced essential amino acids mixture to counteract muscle deterioration in FSHD
Exercise
BehavioralTailored exercise
Diet
BehavioralTailored balanced diet
Placebo Control
Other interventionPlacebo, diet and exercise in FSHD
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Exercise, diet and amino acids in FSHDExperimental treatment 3 interventions
Group B: Exercise, diet and placebo in FSHDPlacebo comparator 3 interventions
Group C: Exercise and diet in healthy controlOther 2 interventions
Trial outcomes
Primary outcomes
1
Change in fat mass in FSHD
Change in fat mass (kg) Time Frame: Baseline, after each 6-month intervention phase Fat mass will be assessed to evaluate changes following amino acid supplementation compared to placebo in participants with FSHD undergoing a standardized nutritional and exercise program.
Time frame
From enrollment to the end of treatment at 15 months2
Change in fat-free mass in FSHD
Change in fat-free mass (kg) Time Frame: Baseline, after each 6-month intervention phase Fat-free mass will be assessed to evaluate changes following amino acid supplementation compared to placebo.
Time frame
From enrollment to the end of treatment at 15 months3
Change in aerobic capacity in FSHD
Change in maximal oxygen consumption (VO₂max) (mL/kg/min) Time Frame: Baseline, after each 6-month intervention phase VO₂max will be measured to assess changes in aerobic capacity following amino acid supplementation compared to placebo.
Time frame
From enrollment to the end of treatment at 15 months4
Change in muscle strength in FSHD
Change in handgrip strength (kg) Time Frame: Baseline, after each 6-month intervention phase Handgrip strength will be measured using a dynamometer to evaluate changes in muscle strength following amino acid supplementation compared to placebo.
Time frame
From enrollment to the end of treatment at 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov