Cerebrospinal Fluid Kinetics of Urolithin A

ConditionHealthy Adult

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAmazentis SA

About this trial

The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Healthy male and female participants aged between 18 and 45 years (both inclusive);

2. Non-smoker subject or smoker of not more than 5 cigarettes a day;

3. Body Mass Index (BMI) between 18.50-30.00 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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Mitopure
Dietary supplement
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Placebo
Dietary supplement
Placebo supplement

Treatment groups

40 Participants

are divided into 5 treatment groups

Group A: Biospecimen Time 1Experimental treatment 2 interventions

Group B: Biospecimen Time 2Experimental treatment 2 interventions

Group C: Biospecimen Time 3Experimental treatment 2 interventions

Group D: Biospecimen Time 4Experimental treatment 2 interventions

Group E: Biospecimen Time 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

CSF:plasma ratio

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

Time frame

24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amazentis SA

Lead sponsor

Mprex Healthcare Pvt. Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: