The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged A⦠(NCT07231783) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Urolithin A (MitopureĀ®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults
Ireland120 participantsStarted 2025-12-10
Plain-language summary
This is a randomised, double-blind, placebo-controlled, parallel study to assess the effects of Urolithin A (MitopureĀ®) supplementation on muscle strength and performance in healthy middle-aged adults. Participants will be randomized to consume MitopureĀ® (500 mg), MitopureĀ® (1000 mg), or placebo once daily for 6 months.
Who can participate
Age range40 Years ā 65 Years
SexALL
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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 abstinenā¦