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

Amazentis SA42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

MitopureDIETARY_SUPPLEMENT

Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily

PlaceboDIETARY_SUPPLEMENT

Softgel containing only excipients. 4 soft-gels to be taken daily

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Australian Catholic University/Australian Institute of Sports

Canberra, Australia

Outcomes

Primary Outcomes

Change in plasma levels over time of creatine kinase (CK)

Muscle damage and recovery biomarker

Time frame: 4 weeks

Change in race performance time during a 3000 m track race in elite runners

Time frame: 4-weeks

Secondary Outcomes

Change from baseline in aerobic capacity (VO2max)

Time frame: 4-weeks

Change from baseline in running economy via indirect calorimetry

Time frame: 4-weeks

Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)

Time frame: 4-weeks

Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)

Time frame: 4-weeks

Change from baseline in Resting Metabolic Rate (RMR)

Time frame: 4-weeks

Change from baseline in maximal muscle strength during 1-repetition maximum leg press

Time frame: 4-weeks

change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)

only in sub-elite runners

Time frame: 4-weeks

Change in acylcarnitines levels via metabolomics in plasma

Time frame: 4-weeks

Data from ClinicalTrials.gov

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