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

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance in Athletes

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Mitopure; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Canberra, Australia
    • Australian Catholic University/Australian Institute of Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supplement containing Mitopure	Dietary supplement: Mitopure; Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
Placebo Comparator: Placebo Supplement	Dietary supplement: Placebo; Softgel containing only excipients. 4 soft-gels to be taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma levels over time of creatine kinase (CK)	Muscle damage and recovery biomarker	4 weeks
Change in race performance time during a 3000 m track race in elite runners		4-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in aerobic capacity (VO2max)		4-weeks
Change from baseline in running economy via indirect calorimetry		4-weeks
Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)		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)	only in sub-elite runners	4-weeks
Change in acylcarnitines levels via metabolomics in plasma		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

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: Australian Catholic University
• Investigators: Principal Investigator: Louise Burke, OAM PhD, Australian Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21.01.AMZ/ENDURO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No