Bioavailability of four Urolithin A (Mitopure) food supplement formulations in healthy adults Other
Conditions
Interventions
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
Sponsors
Amazentis (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximal plasma concentration (Cmax) of Urolithin A measured using repeated blood samples over 72 hours 2. Exposure to Urolithin A measured using area under the curve (AUC) of Urolithin A plasma concentrations over 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events recorded throughout the study | — |
Countries
India
Contacts
Public ContactBrad Currier
Outcome results
None listed