An interventional study of Resveratrol in Mitochondrial Myopathies and Fatty Acid Oxidation Defects, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Treatment
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.
Study design: double-blind, randomized, placebo-controlled, cross-over study.
To ensure enough participants, and due to the risk of a heterogeneous cohort, a cross-over design is chosen, where participants are their own controls. 10 patients with mitochondrial myopathy and 10 patients with fatty acid oxidation defects will be included. Eligible patients will be randomized using a 1:1 assignment ratio to receive placebo or RSV first. Each treatment will be administered orally twice daily for 8 weeks, followed by a 4 weeks wash-out, and afterwards a new 8-week treatment period.
During the 20-week trial period, subjects will visit the trial site on five occasions, for functional assessments (cycle ergometer testing), blood sampling and questionnaires.
47 studies on the registry are indexed under Mitochondrial Myopathies; 13 are open to participants now.
This study's enrollment of 20 is below the median of 24 across 33 interventional studies indexed under Mitochondrial Myopathies.
Browse Mitochondrial Myopathies studies →Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Resveratrol
Over the counter supplement
Dietary Supplement: Resveratrol
Resveratrol supplementation 1000 mg /day or placebo
Heart rate
Decrease in heart rate during constant load cycling exercise.
Time frame: 20 weeks
Peak oxygen utilization
VO\^2max (ml/min)
Time frame: 20 weeks
Fatty acid oxidation
Fatty acid oxidation will be assessed by stable isotope technique (only for fatty acid oxidation defect disease subgroup)
Time frame: 20 weeks
Perceived exertion
Evaluation of perceived exertion (Borg score) during constant workload cycling
Time frame: 20 weeks
Fatigue Severity Scale score
Evaluation of self-rated fatigue
Time frame: 20 weeks
SF-36 questionnaire
Evaluation of self-rated daily function scores
Time frame: 20 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Resveratrol
Copenhagen University Hospital, Rigshospitalet