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Healthy AgingATLAS 2NCT07231783

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

A study testing Mitopure® 500mg and Mitopure® 1000mg in people with Healthy Aging and Muscle Function, run by Amazentis SA at 1 site in Ireland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Muscle Function
What is being tested?
Mitopure® 500mg and Mitopure® 1000mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteIreland
Study dates
10 Dec 2025to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brad Currier, PhD contact

+41 215521272

bcurrier@timeline.com

Anurag Singh, MD, PhD contact

Ireland1 site, 1 recruiting

  • Atlantia Clinical Trials

    Cork, T23 R50R

    Nontokozo Yusuff, MD, +353 (0) 21-430-7442, nyusuff@atlantiatrials.com

    Nontokozo Yusuff, MD

    Recruiting

Other trials in Ireland

About this study

Official title: 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 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.

Being tested
Placebo, Mitopure® 500mg, Mitopure® 1000mg
Keywords
Urolithin A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Placebo softgels

  • Mitopure® 500mgDietary supplement

    Softgels providing 500 mg of Mitopure®

  • Mitopure® 1000mgDietary supplement

    Softgels providing 1000 mg of Mitopure®

Study groups in NCT07231783
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo
500 mg Mitopure®ExperimentalNot described
Receives: Dietary Supplement: Mitopure® 500mg
1000 mg Mitopure®ExperimentalNot described
Receives: Dietary Supplement: Mitopure® 1000mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum isokinetic knee flexion strength

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

    Measured: 6 months

Secondary outcomes (8)

  1. Maximum isokinetic knee flexion strength

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

    Measured: 4 months

  2. Maximum isokinetic knee extension strength

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

    Measured: 4, 6 months

  3. Maximum isometric knee flexion strength

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

    Measured: 4, 6 months

  4. Maximum isometric knee extension strength

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

    Measured: 4, 6 months

  5. Maximum shoulder flexion strength

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

    Measured: 4, 6 months

  6. Maximum shoulder extension strength

    Change in maximum shoulder extension strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

    Measured: 4, 6 months

  7. Body composition (lean mass)

    Change in lean mass between Mitopure® groups and placebo measured by dual-energy X-ray absorptiometry (unit: kg)

    Measured: 4, 6 months

  8. Physical performance (vertical jump)

    Change in physical performance between Mitopure® groups and placebo measured by maximum vertical jump height (unit: cm)

    Measured: 4, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start10 Dec 2025
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07231783
Sponsor's protocol ID
AFCRO-197
Acronym
ATLAS 2
Status last verified
Dec 2025
First submitted
14 Nov 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mitopure® 500mg and Mitopure® 1000mg in people with Healthy Aging and Muscle Function, run by Amazentis SA at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brad Currier, PhD (+41 215521272, bcurrier@timeline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum isokinetic knee flexion strength (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07231783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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