Cerebrospinal Fluid Kinetics of Urolithin A

ConditionHealthy Adult

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

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

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;

Disqualifiers

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

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

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