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

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ClinicalTrials.gov Identifier: NCT04783207
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Australian Catholic University
Information provided by (Responsible Party):
Amazentis SA

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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 : April 21, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Trained elite and sub-elite male runners will participate in a sports training camp
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783207


Contacts
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Contact: Anurag Singh, MD, PhD +41215521274 asingh@amazentis.com

Locations
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Australia
Australian Catholic University/Australian Institute of Sports Recruiting
Canberra, Australia
Contact: Louise Burke, OAM PhD APD         
Sponsors and Collaborators
Amazentis SA
Australian Catholic University
Investigators
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Principal Investigator: Louise Burke, OAM PhD Australian Catholic University
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Responsible Party: Amazentis SA
ClinicalTrials.gov Identifier: NCT04783207    
Other Study ID Numbers: 21.01.AMZ/ENDURO
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No