The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorAmazentis SA
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
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.
Trial design
Treatments tested in this trial
- Placebo
- Mitopure® 500mg
- Mitopure® 1000mg
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Amazentis SA
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov