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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2023-08-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Supplement containing Mitopure

Group Type ACTIVE_COMPARATOR

Mitopure

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Mitopure

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes