Mitochondrial Myopathies Clinical Trial
Official title:
Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders: A Double-blind, Placebo-controlled, Cross Over Study
Verified date | November 2019 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the potential beneficial effects of a daily supplement of Resveratrol (1000mg/day) on physical ability and on muscle metabolism in patients with verified mitochondrial myopathy and patients with a verified fatty acid oxidation defect of VLCAD and CPTII deficiencies. Investigators hypothesize an improved muscle metabolism, mitochondrial function, fatty acid oxidation and thus improvement of physical ability.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patient is willing and able to provide written informed consent prior to participation. 2. Patient is =18 and =80 years of age at baseline. 3. Patients have genetically verified mitochondrial disorder or a fatty acid oxidation deficiency (VLCAD/CPTII). 4. Patient has a clinical presentation, signs or symptoms suggestive of myopathy (e.g., easy fatigability, exercise intolerance, muscle pain) in the opinion of the Investigator. 5. Patient is ambulatory. Exclusion Criteria: 1. Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements. 2. Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction (e.g., drug-induced myopathy). 3. Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments. 4. Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen Neuromuscular Center | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate | Decrease in heart rate during constant load cycling exercise. | 20 weeks | |
Secondary | Peak oxygen utilization | VO^2max (ml/min) | 20 weeks | |
Secondary | Fatty acid oxidation | Fatty acid oxidation will be assessed by stable isotope technique (only for fatty acid oxidation defect disease subgroup) | 20 weeks | |
Secondary | Perceived exertion | Evaluation of perceived exertion (Borg score) during constant workload cycling | 20 weeks | |
Secondary | Fatigue Severity Scale score | Evaluation of self-rated fatigue | 20 weeks | |
Secondary | SF-36 questionnaire | Evaluation of self-rated daily function scores | 20 weeks |
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