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

Sponsor

Amazentis SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04783207

Collaborator

Australian Catholic University (Other)

Enrollment

Location

Arms

20.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Mitopure Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 21, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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) [4-weeks]
only in sub-elite runners
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Australian Catholic University/Australian Institute of Sports	Canberra		Australia

Sponsors and Collaborators

Amazentis SA
Australian Catholic University

Investigators

Principal Investigator: Louise Burke, OAM PhD, Australian Catholic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amazentis SA

ClinicalTrials.gov Identifier:

NCT04783207

Other Study ID Numbers:

21.01.AMZ/ENDURO

First Posted:

Mar 5, 2021

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2022