The effect of four Mitopure food supplement formulations on the amount of Urolithin A in blood
| ISRCTN | ISRCTN60173424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60173424 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Sponsor | Amazentis (Switzerland) |
| Funder | Amazentis |
- Submission date
- 27/10/2025
- Registration date
- 28/10/2025
- Last edited
- 17/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Mitopure is a food supplement that contains Urolithin A, which is a natural molecule. The purpose of this study is to determine the amount of Urolithin A in blood after consuming four different Mitopure formulations.
Who can participate?
Healthy males and females age 18-45 years.
What does the study involve?
Eligible participants will consume a single dose of one of four randomly assigned Mitopure formulations. A blood sample will be collected before the dose and 1, 4, 6, 8, 12, 24 and 72 hours after the dose (eight total blood samples) to measure the amount of Urolithin A in blood.
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. Mitopure is a food supplement that has been sold in the market and thoroughly researched for its safety and effectiveness. 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).
Where is the study run from?
The study will be run at Lokmanya Medical Research Centre and Hospital in Pune, (India)
When is the study starting and how long is it expected to run for?
November 2025 to March 2026
Who is funding the study?
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 (0)215521272 |
| bcurrier@timeline.com |
Principal investigator
Ground Floor Gunjkar Multispeciality Hospital
Spine Road Shivtej Nagar
Chinchwad
Pune
411019
India
| Phone | +91 (0)8454859082 |
|---|---|
| drrammudhe.gunjkarresearch@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label parallel-arm single-period single-dose single-centre randomized study |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Comparative pharmacokinetics of Urolithin A (Mitopure) formulations in healthy adults: a randomized, open-label, single-dose, parallel-arm study |
| Study acronym | MHC/CT/25-26/017 |
| Study objectives | The purpose of this study is to compare the pharmacokinetic profile of four different Urolithin A (Mitopure) formulations. |
| Ethics approval(s) |
Approved 18/10/2025, Institutional Ethics Committee Sangvi Multispeciality Hospital (S. No. 71/1/2/189, C.S. 2387 Krushna Chowk, Krushna Nagar, New Sangvi, Pune, 411027, India; +91 (0)8090109797; iecsangvihospital@gmail.com), ref: ECR/1865/Inst/MH/2023 |
| Health condition(s) or problem(s) studied | Bioavailability of four Urolithin A (Mitopure) food supplement formulations in healthy adults |
| Intervention | Participants will be randomized with a computer-generated list to consume a single oral dose of one nutritional formulation, each providing 500 mg of Urolithin A: 1. Mitopure (Urolithin A) Formulation A (reference group), or 2. Mitopure (Urolithin A) Formulation B, or 3. Mitopure (Urolithin A) Formulation C, or 4. Mitopure (Urolithin A) Formulation D |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Maximal plasma concentration (Cmax) of Urolithin A measured using repeated blood samples over 72 hours |
| Key secondary outcome measure(s) |
Adverse events and serious adverse events recorded throughout the study |
| Completion date | 15/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 1. Healthy male and female participants aged between 18 and 45 years (both inclusive) 2. Non-smoker subject or smoker of not more than five cigarettes a day 3. Body Mass Index (BMI) between 18.5-30 kg/m2 inclusive 4. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests), individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator 5. Normal electrocardiogram (ECG) recording on a 12-lead ECG and/or chest X-ray (PA view) significant at the screening visit or considered not clinically significant (NCS) by investigators 6. A negative alcohol breath test result at housing 7. Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration 8. Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee 9. Ability to fast for at least 14 hours and consume standard meals 10. Accept to refrain consuming certain foods and supplements at least two weeks before inclusion 11. Female participants must have a negative urine pregnancy test prior to housing 12. Trial participants that can provide adequate evidence of their identity 13. The participants agree to refrain from consuming dietary supplements that could potentially impact either muscle or mitochondrial function or contain Urolithin A, such as resveratrol, pomegranate and ellagitannins, nicotinamide riboside, whey protein, leucine, iso-leucine, l-carnitine, creatinine, coenzyme Q10, vitamin A, niacin, folic acids, vitamin C, vitamin E and probiotic foods and supplements, during the 2 weeks before inclusion and throughout the study 14. Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 7 days after completion of the study 15. Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc during the study and 7 days after completion of the study |
| Key exclusion criteria | 1. Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance 2. Any history or presence of clinically significant medical condition, such as, but not limited to, cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, thyroid disease, adrenal dysfunction, or organic intracranial lesion 3. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study 4. History or presence of alcoholism or drug abuse 5. History or presence of gastric and/or duodenal ulceration 6. History or presence of cancer 7. Difficulty with donating blood 8. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study 9. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study 10. Trial participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48 hours before initiation of the study and throughout the study 11. Trial participant consumed caffeine and/or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc) and grapefruit juice and poppy-containing foods for at least 48 hours before initiation of the study and throughout the study 12. Major illness during the 90 days before screening 13. Participation in a drug research study within 90 days of screening 14. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL 15. History or presence of easy bruising or bleeding 16. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the 4 weeks preceding the study 17. Females of childbearing potential with any one of the following reported and documented on the medical history: 17.1. Postmenopausal with spontaneous amenorrhea for at least one year, or 17.2. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or 17.3. Total hysterectomy and an absence of bleeding for at least 3 months 17.4. Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 7 days before dosing 18. Pregnant women and nursing mothers 19. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception like non-hormonal intrauterine devices, barrier methods, and spermicidal agents, double barrier method (condom) during the study till 7 days after the completion of the study 20. Male volunteers willing to donate sperm during the study till 7 days after the completion of the study 21. Allergy to peanuts, nuts, pea, or gum guar |
| Date of first enrolment | 03/11/2025 |
| Date of final enrolment | 15/03/2026 |
Locations
Countries of recruitment
- India
Study participating centre
Mumbai Pune Bypass Road Flyover
Punawale
Pune
411033
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/11/2025: The date of first enrolment was changed from 30/11/2025 to 03/11/2025.
28/10/2025: Study's existence confirmed by the Institutional Ethics Committee Sangvi Multispeciality Hospital.
