NCT04783207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

February 5, 2021

Last Update Submit

August 30, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

    Muscle damage and recovery biomarker

    4 weeks

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

    4-weeks

Secondary Outcomes (12)

  • Change from baseline in aerobic capacity (VO2max)

    4-weeks

  • Change from baseline in running economy via indirect calorimetry

    4-weeks

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

    4-weeks

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

    4-weeks

  • Change from baseline in Resting Metabolic Rate (RMR)

    4-weeks

  • +7 more secondary outcomes

Study Arms (2)

Supplement containing Mitopure

ACTIVE COMPARATOR
Dietary Supplement: Mitopure

Placebo Supplement

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

MitopureDIETARY_SUPPLEMENT

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

Supplement containing Mitopure
PlaceboDIETARY_SUPPLEMENT

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

Placebo Supplement

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTrained elite and sub-elite male runners will participate in a sports training camp
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian Catholic University/Australian Institute of Sports

Canberra, Australia

Location

Study Officials

  • Louise Burke, OAM PhD

    Australian Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

March 5, 2021

Study Start

April 21, 2021

Primary Completion

May 30, 2022

Study Completion

August 30, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)