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

Healthy Clinical Trial

— ENDURO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783207
• Other study ID #: 21.01.AMZ/ENDURO
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Amazentis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mitopure
Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
• Placebo
Softgel containing only excipients. 4 soft-gels to be taken daily

Locations

Country	Name	City	State
Australia	Australian Catholic University/Australian Institute of Sports	Canberra

Sponsors (2)

Lead Sponsor	Collaborator
Amazentis SA	Australian Catholic University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma levels over time of creatine kinase (CK)	Muscle damage and recovery biomarker	4 weeks
Primary	Change in race performance time during a 3000 m track race in elite runners		4-weeks
Secondary	Change from baseline in aerobic capacity (VO2max)		4-weeks
Secondary	Change from baseline in running economy via indirect calorimetry		4-weeks
Secondary	Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)		4-weeks
Secondary	Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)		4-weeks
Secondary	Change from baseline in Resting Metabolic Rate (RMR)		4-weeks
Secondary	Change from baseline in maximal muscle strength during 1-repetition maximum leg press		4-weeks
Secondary	change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)	only in sub-elite runners	4-weeks
Secondary	Change in acylcarnitines levels via metabolomics in plasma		4-weeks
Secondary	change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)		4-weeks
Secondary	change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)		4-weeks
Secondary	change in plasma levels of Urolithin A		4-weeks
Secondary	change in plasma levels of inflammatory marker CRP		4-weeks