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 - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Gunjkar Multispeciality Hospital

Pune, 411062, 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: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)