Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT04783207
- Lead Sponsor
- Amazentis SA
- Brief Summary
This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
- Age between 18-40 years
- Participants will be running >100 km/week
- Elite participants will be required to have a 3,000 m running personal best time below 9:00 (mm:ss), and/or a VO2max result greater than 65 ml·kg-1·min-1
- The sub-elite cohort will have a 3,000 m running personal best faster than 10:00 min and/or a VO2max >60 ml·kg-1·min-1
- Agree to participate in one of two ~4 week training camps been held between March-October 2021.
- Signed informed consent
Exclusion Criteria
- Subjects with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
- Subjects who are unable to complete the training or testing protocols
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in race performance time during a 3000 m track race in elite runners 4-weeks Change in plasma levels over time of creatine kinase (CK) 4 weeks Muscle damage and recovery biomarker
- Secondary Outcome Measures
Name Time Method Change from baseline in running economy via indirect calorimetry 4-weeks Change from baseline in maximal muscle strength during 1-repetition maximum leg press 4-weeks change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO) 4-weeks only in sub-elite runners
Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA) 4-weeks change in plasma levels of inflammatory marker CRP 4-weeks change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only) 4-weeks change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only) 4-weeks Change from baseline in Resting Metabolic Rate (RMR) 4-weeks Change in acylcarnitines levels via metabolomics in plasma 4-weeks Change from baseline in aerobic capacity (VO2max) 4-weeks Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA) 4-weeks change in plasma levels of Urolithin A 4-weeks
Trial Locations
- Locations (1)
Australian Catholic University/Australian Institute of Sports
🇦🇺Canberra, Australia
Australian Catholic University/Australian Institute of Sports🇦🇺Canberra, Australia