Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Mitopure; Dietary Supplement: Placebo

• 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

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Study Start: 2021-04-21
• Primary Completion: 2022-05-30
• Status Verified: 2023-08
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

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

Arm && Interventions

Group	Intervention	Description
Supplement containing Mitopure	Mitopure	-
Placebo Supplement	Placebo	-

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 in plasma levels of Urolithin A	4-weeks
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

Trial Locations

Locations (1)

Australian Catholic University/Australian Institute of Sports; 🇦🇺 Canberra, Australia