Healthy Adult
Conditions
Keywords
Mitopure, Urolithin A
Brief summary
The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).
Interventions
DIETARY_SUPPLEMENTMitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
DIETARY_SUPPLEMENTPlacebo
Placebo supplement
Sponsors
Amazentis SA
Mprex Healthcare Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a randomized (3:1), quintuple-cohort, double-blind, placebo-controlled trial. Subjects will be randomized with validated software to one cohort; within each cohort, subjects will be randomized to one of two test products (active or placebo)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female human participant aged between 18 and 45 years (both inclusive); * Participants with a body mass index (BMI) between 18.50-30.00 kg/m2 * and body mass, not less than 50.00 kg; * Female participant must have a negative urine pregnancy test prior to the housing; * Females of childbearing potential agreeing to use appropriate * contraceptive measures like non hormonal intrauterine device, barrier methods, spermicidal agents during the study and 07 days after completion of the study; * Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study; * 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); * Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording; * Participants having a normal or clinically not significant chest X-ray (PA view); * A negative alcohol breath test result; * Participant able to communicate effectively and provide written informed consent; * Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee; * Participants that can provide adequate evidence of their identity; * Availability of volunteers for the entire study duration; * Ability to fast for at least 14.00 hours and consume standard meals. * Participants with normal hemoglobin levels as follows: Males:14 to 18 g/dl (both inclusive); Females: 12 to 16 g/dl (both inclusive).
Exclusion criteria
* Known hypersensitivity to Urolithin A or related product or any component of this intervention; * Incapable of understanding the informed consent information; * Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities; * Any treatment which could bring about induction or inhibition of the * hepatic microsomal enzyme system within one month of starting the study; * History or presence of alcoholism or drug abuse; * History or presence of asthma, urticaria, or other allergic reactions; * History or presence of gastric and/or duodenal ulceration; * History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion; * History or presence of cancer; * 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; * Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study; * Smokers who smoke 9 or more cigarettes/day or inability to abstain * during the study; * Participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study; * Major illness during the 90 days before screening; * Participation in a drug research study within 90 days of screening; * Donation of blood within 90 days of screening; * Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL; * History or presence of easy bruising or bleeding; * Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study; * Females of childbearing potential with any one of the following reported and documented on the medical history: * Postmenopausal with spontaneous amenorrhea for at least one year, or * Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or * Total hysterectomy and an absence of bleeding for at least 3 months. * Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing; * Pregnant women and nursing mothers; * Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study. * Allergy to peanuts, nuts, pea, or gum guar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF:plasma ratio | 24 hours | Participants will have their cerebral spinal fluid 1, 3, 6, 12, or 24 hours after Mitopure consumption. Outcome measure is the ratio of urolithin A concentration in cerebral spinal fluid:plasma |
Countries
India
Contacts
CONTACTBrad Currier, PhD
CONTACTAnurag Singh, MD, PhD
Outcome results
None listed