Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMitopure
Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
DIETARY_SUPPLEMENTPlacebo
Softgel containing only excipients. 4 soft-gels to be taken daily
Sponsors
Australian Catholic University
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma levels over time of creatine kinase (CK) | 4 weeks | Muscle damage and recovery biomarker |
| Change in race performance time during a 3000 m track race in elite runners | 4-weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 from baseline in Resting Metabolic Rate (RMR) | 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 running economy via indirect calorimetry | 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 in plasma levels of Urolithin A | 4-weeks | — |
| change in plasma levels of inflammatory marker CRP | 4-weeks | — |
| Change in acylcarnitines levels via metabolomics in plasma | 4-weeks | — |
| Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA) | 4-weeks | — |
Countries
Australia
Outcome results
None listed