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Completed

NCT Number: NCT04783207

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Australian Catholic University/Australian Institute of Sports

Canberra, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitopure

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

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

    Time frame: 4 weeks

    Muscle damage and recovery biomarker

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

    Time frame: 4-weeks

Secondary outcomes

  1. Change from baseline in aerobic capacity (VO2max)

    Time frame: 4-weeks

  2. Change from baseline in running economy via indirect calorimetry

    Time frame: 4-weeks

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

    Time frame: 4-weeks

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

    Time frame: 4-weeks

  5. Change from baseline in Resting Metabolic Rate (RMR)

    Time frame: 4-weeks

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

    Time frame: 4-weeks

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

    Time frame: 4-weeks

    only in sub-elite runners

  8. Change in acylcarnitines levels via metabolomics in plasma

    Time frame: 4-weeks

  9. change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)

    Time frame: 4-weeks

  10. change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)

    Time frame: 4-weeks

  11. change in plasma levels of Urolithin A

    Time frame: 4-weeks

  12. change in plasma levels of inflammatory marker CRP

    Time frame: 4-weeks

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Australian Catholic University

Registry information

Official study 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

Acronym: ENDURO

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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