Cerebrospinal Fluid Kinetics of Urolithin A

NCT07517913 | Not Yet Recruiting

• 1 other identifier: neURO-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Adult

Keywords

Mitopure; Urolithin A

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Study Arms (5)

Biospecimen Time 1

EXPERIMENTAL

Cerebrospinal fluid will be collected at timepoint 1

Dietary Supplement: Mitopure; Dietary Supplement: Placebo

Biospecimen Time 2

EXPERIMENTAL

Cerebrospinal fluid will be collected at timepoint 2

Dietary Supplement: Mitopure; Dietary Supplement: Placebo

Biospecimen Time 3

EXPERIMENTAL

Cerebrospinal fluid will be collected at timepoint 3

Dietary Supplement: Mitopure; Dietary Supplement: Placebo

Biospecimen Time 4

EXPERIMENTAL

Cerebrospinal fluid will be collected at timepoint 4

Dietary Supplement: Mitopure; Dietary Supplement: Placebo

Biospecimen Time 5

EXPERIMENTAL

Cerebrospinal fluid will be collected at timepoint 5

Dietary Supplement: Mitopure; Dietary Supplement: Placebo

Interventions

Mitopure DIETARY_SUPPLEMENT

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

Biospecimen Time 1; Biospecimen Time 2; Biospecimen Time 3; Biospecimen Time 4; Biospecimen Time 5

Placebo DIETARY_SUPPLEMENT

Placebo supplement

Biospecimen Time 1; Biospecimen Time 2; Biospecimen Time 3; Biospecimen Time 4; Biospecimen Time 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy male and female participants aged between 18 and 45 years (both inclusive);
• \. Non-smoker subject or smoker of not more than 5 cigarettes a day;
• \. Body Mass Index (BMI) between 18.50-30.00 kg/m2 inclusive;
• \. 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;
• \. 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;
• \. A negative alcohol breath test result at housing;
• \. Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration;
• \. Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;
• \. Ability to fast for at least 14.00 hours and consume standard meals;
• \. Female participants must have a negative urine pregnancy test prior to housing;
• \. Trial participants that can provide adequate evidence of their identity;
• \. Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and 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.

You may not qualify if:

• \. Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance;
• \. 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;
• \. 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 gastric and/or duodenal ulceration;
• \. History or presence of cancer;
• \. Difficulty with donating blood;
• \. 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;
• \. Trial 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;
• \. 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 48.00 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;
• \. 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;

Sponsors & Collaborators

• Amazentis SA: lead
• Mprex Healthcare Pvt. Ltd.: collaborator

Study Sites (1)

Lokmanya Medical Research Centre and Hospital

Pune, India

Location

Central Study Contacts

Brad Currier, PhD

CONTACT

+41215521272; bcurrier@timeline.com

Anurag Singh, MD, PhD

CONTACT

asingh@amazentis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)