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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Healthy Aging, Muscle Function

In brief

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.

Key facts

Study ID

NCT07231783

Run by

Amazentis SA

People needed

120

Starts

2025-12-10

Expected to finish

2027-10-31

Last updated by the study team

2026-03-31

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 6. Participants who are unable to swallow capsules.
• 7. Is hypersensitive to or has dietary restrictions for any of the components of the Study Product e.g., gelatine
• 8. Unstable body weight or recent participation in a weight loss program (within 12-weeks prior to screening).
• 9. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
• a. Major illness/surgery in the 12-weeks prior to screening
• b. Diagnosed cardiovascular disease (NHYA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmia, uncontrolled hypertension)
• c. Diagnosed liver disease (cirrhosis, end stage liver disease)
• d. Diagnosed kidney disease (stage 3b or 4 chronic kidney disease, or kidney failure)
• e. Diagnosed gastrointestinal disease (IBS/IBD, diarrhoea, Acid Reflux)
• f. Uncontrolled thyroid conditions
• g. Uncontrolled diabetes
• h. Metallic implants
• i. Conditions requiring chemotherapy or immunotherapy.
• 10. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
• a. Statins or other medications known to impair mitochondrial function.

Where it is running

• Atlantia Clinical Trials — Cork, Ireland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.