We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03728777
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 27, 2019
Information provided by (Responsible Party):
Nicoline Løkken, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE April 9, 2018
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Heart rate [ Time Frame: 20 weeks ]
Decrease in heart rate during constant load cycling exercise.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Peak oxygen utilization [ Time Frame: 20 weeks ]
    VO^2max (ml/min)
  • Fatty acid oxidation [ Time Frame: 20 weeks ]
    Fatty acid oxidation will be assessed by stable isotope technique (only for fatty acid oxidation defect disease subgroup)
  • Perceived exertion [ Time Frame: 20 weeks ]
    Evaluation of perceived exertion (Borg score) during constant workload cycling
  • Fatigue Severity Scale score [ Time Frame: 20 weeks ]
    Evaluation of self-rated fatigue
  • SF-36 questionnaire [ Time Frame: 20 weeks ]
    Evaluation of self-rated daily function scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders
Official Title  ICMJE Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders: A Double-blind, Placebo-controlled, Cross Over Study
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
double-blind, randomized, placebo-controlled, cross-over study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitochondrial Myopathies
  • Fatty Acid Oxidation Defects
Intervention  ICMJE Dietary Supplement: Resveratrol
Resveratrol supplementation 1000 mg /day or placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: Resveratrol
    Over the counter supplement
    Intervention: Dietary Supplement: Resveratrol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03728777
Other Study ID Numbers  ICMJE H-17039503
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Nicoline Løkken, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Vissing, professor Copenhangen Neuromuscular Center, Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP