The influence of exercise on the energy generating capacity of the mitochondria: could exercise offer a solution?
Phase 1
- Conditions
- Asymp and symp statin users will undergo baseline measurements of skeletal muscle mitochondrial function and muscle function after which they will be switched to a single-blind placebo intervention for 12 weeks. Then the same measurements will be repeated. Hereafter, only the symptomatic statin users will continue with the intervention en will be randomely allocated to: atorvastatin, atorvastin+exercise or placebo+exercise for another 12 weeks. Then the same measurements will be repeated again.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2015-000462-62-NL
- Lead Sponsor
- Radboud university medical centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
age: 18-70 years old
current statin users
mentally able/allowed to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
familial hypercholesterolemia
impaired liver function
hereditary muscle defect
kidney insufficiency
unwillingness to abstain from grapefruit juice during the intervention
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method