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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 : October 18, 2021
Sponsor:
Collaborator:
Australian Catholic University
Information provided by (Responsible Party):
Amazentis SA

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE March 5, 2021
Last Update Posted Date October 18, 2021
Actual Study Start Date  ICMJE April 21, 2021
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • Change in plasma levels over time of creatine kinase (CK) [ Time Frame: 4 weeks ]
    Muscle damage and recovery biomarker
  • Change in race performance time during a 3000 m track race in elite runners [ Time Frame: 4-weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • 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) [ Time Frame: 4-weeks ]
    only in sub-elite runners
  • Change in acylcarnitines levels via metabolomics in plasma [ Time Frame: 4-weeks ]
  • change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only) [ Time Frame: 4-weeks ]
  • change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only) [ Time Frame: 4-weeks ]
  • change in plasma levels of Urolithin A [ Time Frame: 4-weeks ]
  • change in plasma levels of inflammatory marker CRP [ Time Frame: 4-weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Mitopure
    Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
  • Dietary Supplement: Placebo
    Softgel containing only excipients. 4 soft-gels to be taken daily
Study Arms  ICMJE
  • Active Comparator: Supplement containing Mitopure
    Intervention: Dietary Supplement: Mitopure
  • Placebo Comparator: Placebo Supplement
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2021)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anurag Singh, MD, PhD +41215521274 asingh@amazentis.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04783207
Other Study ID Numbers  ICMJE 21.01.AMZ/ENDURO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amazentis SA
Study Sponsor  ICMJE Amazentis SA
Collaborators  ICMJE Australian Catholic University
Investigators  ICMJE
Principal Investigator: Louise Burke, OAM PhD Australian Catholic University
PRS Account Amazentis SA
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP