The effect of Urolithin A (Mitopure®) supplementation on muscle strength in healthy middle-aged adults
| ISRCTN | ISRCTN47159002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47159002 |
- Submission date
- 21/10/2025
- Registration date
- 28/10/2025
- Last edited
- 28/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Healthy males and females age 40-65 years.
What does the study involve?
Eligible participants will consume one dose of their randomly assigned food supplement (Mitopure® 500 mg, Mitopure® 1000 mg, or placebo) every day while maintaining their habitual diet and physical activity for 6 months. Measurements of muscle strength, health, and performance will be collected at baseline (before first dose) and after four and six months of supplementation.
What are the possible benefits and risks of participating?
Participation in this study offers no direct benefits to the participants. The study poses negligible risk to participants. The food supplement Mitopure® (Urolithin A) has been established in the market and thoroughly researched for its safety. Participants will be asked to undergo blood sample collection (which might cause pain from the needle going through the skin, bruising, clots under the skin, light-headedness, possible fainting, and, rarely, infection), Dual-Energy X-ray Absorptiometry scans (a non-invasive scan that measures body composition with a very low exposure to radiation. This radiation dose is considered safe to give to humans many times), and fitness testing (which might cause mild muscle soreness and fatigue).
Where is the study run from?
Atlantia Clinical Trials in Cork, Ireland.
When is the study starting and how long is it expected to run for?
Enrolment is planned to begin 15 November 2025 until 30 April 2027, with last-participant last-visit expected 31 October 2027.
Who is funding the study?
The study is funded by Amazentis SA (Switzerland)
Who is the main contact?
Dr Brad Currier (bcurrier@timeline.com)
Contact information
Public, Scientific
Timeline (Amazentis SA)
Swiss Federal Institute of Technology (EPFL)
Building C, Innovation Park
Lausanne
1015
Switzerland
 ORCID ID |
0000-0003-3955-3174 |
|---|---|
| Phone | +41 215521272 |
| bcurrier@timeline.com |
Principal investigator
Heron House, Blackpool Retail Park, Atlantia Clinical Trials, Floor 1, Blackpool
Cork
T23 R50R
Ireland
| Phone | +353 (0) 21-430-7442 |
|---|---|
| tdinan@atlantiatrials.com |
Study information
| Study design | Interventional randomized double-blind placebo-controlled parallel single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Laboratory |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific 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 |
| Study acronym | AFCRO-197 (ATLAS 2.0) |
| Study objectives | The purpose of this study is to determine the impact of Urolithin A (Mitopure®) supplementation on muscle strength and performance in healthy middle-aged adults. |
| Ethics approval(s) |
Approved 09/09/2025, Salus IRB (2111 W Braker Ln #100, Austin, TX 78758, United States, Austin, 78758, United States of America; +1 (512) 380-1244; salus@salusirb.com), ref: AFCRO-197 |
| Health condition(s) or problem(s) studied | Muscle strength in healthy middle-aged adults. |
| Intervention | Participants will be randomized with a list generated by a statistician not involved in the conduct of the study to consume a daily dose of either: 1. Mitopure (Urolithin A dose: 500 mg), or 2. Mitopure (Urolithin A dose: 1000 mg), or 3. Placebo (Urolithin A dose: 0 mg) For all three study arms, the intervention duration is 6 months (24 weeks), and measurements are performed at baseline (week 0), 4 months (week 16), and 6 months (week 24). |
| Intervention type | Other |
| Primary outcome measure | Maximum isokinetic knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline and 6 months. |
| Secondary outcome measures | 1. Maximum isokinetic knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline and 4 months. 2. Maximum isokinetic knee extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 3. Maximum isometric knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 4. Maximum isometric knee extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 5. Maximum shoulder flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 6. Maximum shoulder extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 7. Body composition (lean mass) will be measured by dual-energy X-ray absorptiometry (unit: kg) at baseline, 4, and 6 months. 8. Physical performance (vertical jump) will be measured by maximum vertical jump height (unit: cm) at baseline, 4, and 6 months. Other Pre-Specified (Tertiary) Outcome Measures 9. Cardiovascular fitness (VO2max) will be measured by a graded exercise test (unit: mL/kg/min) at baseline, 4, and 6 months. 10. Physical capacity (time to exhaustion) will be measured by time to exhaustion during the graded exercise test (unit: minutes) at baseline, 4, and 6 months. 11. Physical capacity (maximum cycling distance) will be measured by maximum cycling distance during the graded exercise test (unit: meters) at baseline, 4, and 6 months. 12. Physical performance (30-second chair stand) will be measured by the 30-second chair stand test (unit: repetitions) at baseline, 4, and 6 months. 13. Physical performance (6-minute walk test) will be measured by the 6-minute walk test (unit: meters) at baseline, 4, and 6 months. 14. Physical performance (timed up-and-go) will be measured by the timed up-and-go test (unit: seconds) at baseline, 4, and 6 months. 15. Blood acylcarnitine level will be measured using blood sample analysis at baseline and 6 months. 16. Blood inflammatory markers will be measured using blood sample analysis at baseline and 6 months. 17. Plasma Urolithin A level will be measured using blood sample analysis at baseline and 6 months. 18. Habitual dietary intake will be measured by 3-day diet diary at baseline, 4, and 6 months. 19. Habitual physical activity will be measured by the International Physical Activity Questionnaire at baseline, 4, and 6 months. 20. Daily fatigue will be measured by FACIT-Fatigue questionnaire at baseline, 4, and 6 months. 21. Safety (adverse events) will be monitored by clinical safety reporting at baseline throughout the trial to 6 months. |
| Overall study start date | 15/01/2025 |
| Completion date | 31/10/2027 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target number of participants | 120 |
| Key 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 hours 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 hours before exercise as per study guidelines 8. Willing to consume the Study Product daily for the duration of the study |
| Key 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: 2.1 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 2.2 Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant 2.3 Sexual partner(s) is/are exclusively female 2.4 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 2.5 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: 9.1 Major illness/surgery in the 12 weeks prior to screening 9.2 Diagnosed cardiovascular disease (NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmia, uncontrolled hypertension) 9.3 Diagnosed liver disease (cirrhosis, end stage liver disease) 9.4 Diagnosed kidney disease (stage 3b or 4 chronic kidney disease, or kidney failure) 9.5 Diagnosed gastrointestinal disease (IBS/IBD, diarrhoea, acid reflux) 9.6 Uncontrolled thyroid conditions 9.7 Uncontrolled diabetes 9.8 Metallic implants 9.9 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: 10.1 Statins or other medications known to impair mitochondrial function 10.2 Anxiolytics, antidepressants, sedative hypnotics (in the 8 weeks prior to Visit 1) 10.3 Antipsychotics, monoamine oxidase inhibitors (in the 8 weeks prior to Visit 1) 10.4 Oral anti-infectives (antibiotics, antivirals, antifungals) for acute infections (in the 12 weeks prior to Visit 1) 10.5 Proton pump inhibitors (PPIs) (in the 4 weeks prior to Visit 1) 10.6 Corticosteroids (>5 mg per day in the past 4 weeks prior to Visit 1) 10.7 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: 11.1 Mitopure® containing supplements 11.2 Supplements for muscle strengthening/building or mitochondrial boosting (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 |
| Date of first enrolment | 15/11/2025 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Cork
T23 R50R
Ireland
Sponsor information
Industry
Timeline (Amazentis SA)
Swiss Federal Institute of Technology (EPFL)
Building C, Innovation Park
Lausanne
1015
Switzerland
| Phone | +41 215521272 |
|---|---|
| asingh@amazentis.com | |
| Website | https://www.timeline.com/ |
"ROR" |
https://ror.org/01at1hy26 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amazentis SA
- Location
- Switzerland
Results and Publications
| Intention to publish date | 15/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
21/10/2025: Trial's existence confirmed by Salus IRB.
