Urolithin A (Mitopure) to improve muscle strength in middle-aged adults

A Confirmatory, Randomised, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Effects of a Dietary Supplement Containing Urolithin A (Mitopure®) on Muscle Strength and Performance in Healthy Middle-Aged Adults

This study will test whether taking Mitopure (urolithin A) once daily for six months can improve muscle strength and performance in healthy 40–65-year-olds with low activity and lower aerobic fitness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: Amazentis SA (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Cork)
• Trial ID: NCT07231783 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, parallel-group trial assigning participants to Mitopure 500 mg, Mitopure 1000 mg, or placebo once daily for six months. Eligible volunteers are healthy adults aged 40–65 with BMI 25.0–34.9 kg/m2, low physical activity by IPAQ, and low VO2 peak (<35 mL/kg/min). Outcomes include changes in muscle strength and physical performance measured with standardized strength and aerobic tests at baseline and follow-up visits. The study is sponsored by Amazentis SA and conducted at Atlantia Clinical Trials in Cork, Ireland.

Who should consider this trial

Good fit: Ideal candidates are adults 40–65 years old with BMI 25.0–34.9, low physical activity and VO2 peak below 35 mL/kg/min who can take a daily supplement and attend clinic visits.

Not a fit: People who are highly active, have normal or high aerobic fitness, are outside the listed age or BMI ranges, pregnant or breastfeeding, or unwilling to follow study restrictions are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the supplement could help middle-aged adults with low activity preserve or improve muscle strength and physical performance, potentially slowing age-related decline.

How similar studies have performed: Early human and animal studies of urolithin A have shown improvements in mitochondrial markers and exercise endurance, but large-scale clinical evidence for direct muscle-strength benefits is limited.

Eligibility criteria

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.

Where this trial is running

Cork

• Atlantia Clinical Trials — Cork, Ireland (Recruiting)

Study contacts

• Study coordinator: Brad Currier, PhD

Conditions Healthy Aging; Muscle Function; Urolithin A