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The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults | Clinical Trials | Clareo Health

RECRUITINGNA

The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults

A Confirmatory, Randomised, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Effects of a Dietary Supplement Containing Urolithin A (Mitopure®) on Muscle Strength and Performance in Healthy Middle-Aged Adults

NCT07231783•Amazentis SA

View on ClinicalTrials.gov

Summary

This is a randomised, double-blind, placebo-controlled, parallel study to assess the effects of Urolithin A (Mitopure®) supplementation on muscle strength and performance in healthy middle-aged adults. Participants will be randomized to consume Mitopure® (500 mg), Mitopure® (1000 mg), or placebo once daily for 6 months.

Eligibility

Age

40 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1\. Be able to give written informed consent.
•2\. Be between 40 to 65 years of age, inclusive.
•3\. Has a BMI between 25.0 and 34.9 kg/m2.
•4\. Low physical activity levels as assessed by the International Physical Activity Questionnaire (IPAQ).
•5\. Participants with low VO2 peak (defined as \<35 mL/kg/min via the ergometer prior to baseline).
•6\. Willing to avoid exercising 48-h prior to study visits and maintain low physical activity status for the duration of the study.
•7\. Willing to avoid caffeine and other stimulants (e.g., energy drinks) 12-h before exercise as per study guidelines.
•8\. Willing to consume the Study Product daily for the duration of the study.

Exclusion Criteria

•1\. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
•2\. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
•* a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
•* b. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
•* c. Sexual partner(s) is/are exclusively female.
•* d. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
•* e. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
•3\. Participants with history of drug and/or alcohol abuse at the time of enrolment. (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); alcohol/substance abuse disorder).
•4\. Participants consuming large quantities of pomegranate juice or walnuts or frequent consumers of raspberries, strawberries or cloudberries (2-week washout).
•5\. Chronic nicotine use.
+27 more criteria

Locations (1)

Atlantia Clinical Trials

Cork, Ireland

Key Dates

Start Date

December 10, 2025

Primary Completion Date

October 31, 2027

Completion Date

October 31, 2027

Last Updated

December 12, 2025

Enrollment

120

ESTIMATED participants

Conditions

Healthy AgingMuscle Function

Interventions

Placebo

DIETARY_SUPPLEMENT

Mitopure® 500mg

DIETARY_SUPPLEMENT

Mitopure® 1000mg

DIETARY_SUPPLEMENT

Contacts

Brad Currier, PhD

CONTACT

+41 215521272 bcurrier@timeline.com

Anurag Singh, MD, PhD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults

Inclusion Criteria

Exclusion Criteria

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