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

NCT07231783 | Recruiting

• 1 other identifier: AFCRO-197
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging; Muscle Function

Keywords

Urolithin A

Outcome Measures

Primary Outcomes (1)

• Maximum isokinetic knee flexion strength

  Change in maximum isokinetic knee flexion strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

  6 months

Secondary Outcomes (8)

• Maximum isokinetic knee flexion strength

  4 months

• Maximum isokinetic knee extension strength

  4, 6 months

• Maximum isometric knee flexion strength

  4, 6 months

• Maximum isometric knee extension strength

  4, 6 months

• Maximum shoulder flexion strength

  4, 6 months

Other Outcomes (13)

• Cardiovascular fitness (VO2max)

  4, 6 months

• Physical capacity (time to exhaustion)

  4, 6 months

• Physical capacity (maximum cycling distance)

  4, 6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

500 mg Mitopure®

EXPERIMENTAL

Dietary Supplement: Mitopure® 500mg

1000 mg Mitopure®

EXPERIMENTAL

Dietary Supplement: Mitopure® 1000mg

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo softgels

Placebo

Mitopure® 500mg DIETARY_SUPPLEMENT

Softgels providing 500 mg of Mitopure®

500 mg Mitopure®

Mitopure® 1000mg DIETARY_SUPPLEMENT

Softgels providing 1000 mg of Mitopure®

1000 mg Mitopure®

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• \. 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.
• \. 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).
• \. Participants consuming large quantities of pomegranate juice or walnuts or frequent consumers of raspberries, strawberries or cloudberries (2-week washout).
• \. Chronic nicotine use.
• \. Participants who are unable to swallow capsules.
• \. Is hypersensitive to or has dietary restrictions for any of the components of the Study Product e.g., gelatine
• \. Unstable body weight or recent participation in a weight loss program (within 12-weeks prior to screening).
• \. 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

Sponsors & Collaborators

• Amazentis SA: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, T23 R50R, Ireland

RECRUITING

Central Study Contacts

Brad Currier, PhD

CONTACT

+41 215521272; bcurrier@timeline.com

Anurag Singh, MD, PhD

CONTACT

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: November 14, 2025
• First Posted: November 17, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)