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

NCT03728777 | Completed

• 1 other identifier: H-17039503
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Myopathies; Fatty Acid Oxidation Defects

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Decrease in heart rate during constant load cycling exercise.

  20 weeks

Secondary Outcomes (5)

• Peak oxygen utilization

  20 weeks

• Fatty acid oxidation

  20 weeks

• Perceived exertion

  20 weeks

• Fatigue Severity Scale score

  20 weeks

• SF-36 questionnaire

  20 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Resveratrol

Resveratrol

EXPERIMENTAL

Over the counter supplement

Dietary Supplement: Resveratrol

Interventions

Resveratrol DIETARY_SUPPLEMENT

Resveratrol supplementation 1000 mg /day or placebo

Placebo; Resveratrol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is willing and able to provide written informed consent prior to participation.
• Patient is ≥18 and ≤80 years of age at baseline.
• Patients have genetically verified mitochondrial disorder or a fatty acid oxidation deficiency (VLCAD/CPTII).
• 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.
• Patient is ambulatory.

You may not qualify if:

• 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.
• Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction (e.g., drug-induced myopathy).
• Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen Neuromuscular Center

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Mitochondrial Myopathies

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• John Vissing, professor

  Copenhangen Neuromuscular Center, Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: double-blind, randomized, placebo-controlled, cross-over study.

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: November 2, 2018
• Study Start: April 9, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

DK (1)