New supplement aims to fight age-related muscle loss
NCT ID NCT07231783
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a dietary supplement called Mitopure® (containing urolithin A) can improve muscle strength in healthy middle-aged adults aged 40 to 65 who are not very active. Over 6 months, 120 participants will take either a low or high dose of the supplement or a placebo. The main goal is to see if the supplement increases knee strength compared to the placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urolithin A (Mitopure®) dietary supplement
- What this could lead to
- If it works, this could point toward a simple supplement to help maintain muscle strength during aging.
- What could go wrong
- This is a small, early-stage trial in healthy people, so results may not apply to everyone. The supplement may not improve strength more than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * 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. * b. Anxiolytics, antidepressants, sedative hypnotics (in the 8 weeks prior to visit 1) * c. Antipsychotics, monoamine Oxidase Inhibitors (in the 8 weeks prior to visit 1) * d. Oral anti- infective (antibiotics, antivirals, antifungals) for acute infections (in the 12-weeks prior to visit 1) * e. Proton pump inhibitors (PPIs) (in the 4 weeks prior to visit 1) * f. Corticosteroids (\> 5mg per day in the past 4 weeks prior to visit 1) * g. GLP-1 agonists (in the 8 weeks prior to visit 1) * 11\. Current or recent (in the past 6-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements 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 supplements include: * a. Mitopure® containing supplements * b. Supplements for muscle strengthening/building or mitochondrial boosting supplements (e.g. high protein, Vitamin B3 \[and precursors\], L-carnitine, CoQ10, NAD+, resveratrol) * 12\. Blood donation in the 8-weeks prior to screening. * 13\. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. * 14\. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study (physical or muscle performance), the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlantia Clinical Trials
RECRUITINGCork, T23 R50R, Ireland
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