Cerebrospinal Fluid Kinetics of Urolithin A (neURO)

September 5, 2026 updated by: Amazentis SA

Cerebrospinal Fluid Kinetics of Urolithin A in Humans

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Pune, India, 411062
        • Gunjkar Multispeciality Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biospecimen Time 1
Cerebrospinal fluid will be collected at timepoint 1
Dietary supplement: Mitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Dietary supplement: Placebo
Placebo supplement
Experimental: Biospecimen Time 2
Cerebrospinal fluid will be collected at timepoint 2
Dietary supplement: Mitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Dietary supplement: Placebo
Placebo supplement
Experimental: Biospecimen Time 3
Cerebrospinal fluid will be collected at timepoint 3
Dietary supplement: Mitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Dietary supplement: Placebo
Placebo supplement
Experimental: Biospecimen Time 4
Cerebrospinal fluid will be collected at timepoint 4
Dietary supplement: Mitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Dietary supplement: Placebo
Placebo supplement
Experimental: Biospecimen Time 5
Cerebrospinal fluid will be collected at timepoint 5
Dietary supplement: Mitopure
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Dietary supplement: Placebo
Placebo supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF:plasma ratio
Time Frame: 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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amazentis SA

Collaborators

Mprex Healthcare Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 5, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • neURO-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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