Healthy AdultneURONCT07517913
Cerebrospinal Fluid Kinetics of Urolithin A
A study testing Mitopure in people with Healthy Adult, run by Amazentis SA at 1 site in India.
Trial summary
The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Mitopure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 6 Sep 2026to 4 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Healthy Adult
- Being tested
- Mitopure, Placebo
- Keywords
- Mitopure, Urolithin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitopureDietary supplement
Mitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
PlaceboDietary supplement
Placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Biospecimen Time 1 | Experimental | Cerebrospinal fluid will be collected at timepoint 1 Receives: Dietary Supplement: Mitopure; Dietary Supplement: Placebo |
| Biospecimen Time 2 | Experimental | Cerebrospinal fluid will be collected at timepoint 2 Receives: Dietary Supplement: Mitopure; Dietary Supplement: Placebo |
| Biospecimen Time 3 | Experimental | Cerebrospinal fluid will be collected at timepoint 3 Receives: Dietary Supplement: Mitopure; Dietary Supplement: Placebo |
| Biospecimen Time 4 | Experimental | Cerebrospinal fluid will be collected at timepoint 4 Receives: Dietary Supplement: Mitopure; Dietary Supplement: Placebo |
| Biospecimen Time 5 | Experimental | Cerebrospinal fluid will be collected at timepoint 5 Receives: Dietary Supplement: Mitopure; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start6 Sep 2026
- Primary completion4 Oct 2026
- Study completion4 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mprex Healthcare Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517913
- Sponsor's protocol ID
- neURO-A
- Acronym
- neURO
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Kinetics of Urolithin A in Humans
- ClinicalTrials.gov ID
- NCT07517913
- Acronym / sponsor ID
- neURO / neURO-A
- Conditions
- Healthy Adult
- Keywords
- Mitopure, Urolithin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Mprex Healthcare Pvt. Ltd.
- Study start
- 6 Sep 2026 (actual)
- Primary completion
- 4 Oct 2026 (actual)
- Study completion
- 4 Oct 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Biospecimen Time 1 | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: PlaceboCerebrospinal fluid will be collected at timepoint 1 |
| Biospecimen Time 2 | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: PlaceboCerebrospinal fluid will be collected at timepoint 2 |
| Biospecimen Time 3 | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: PlaceboCerebrospinal fluid will be collected at timepoint 3 |
| Biospecimen Time 4 | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: PlaceboCerebrospinal fluid will be collected at timepoint 4 |
| Biospecimen Time 5 | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: PlaceboCerebrospinal fluid will be collected at timepoint 5 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitopureMitopure is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health | Dietary supplement | Biospecimen Time 1, Biospecimen Time 2, Biospecimen Time 3, Biospecimen Time 4, Biospecimen Time 5 |
| PlaceboPlacebo supplement | Dietary supplement | Biospecimen Time 1, Biospecimen Time 2, Biospecimen Time 3, Biospecimen Time 4, Biospecimen Time 5 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure in people with Healthy Adult, run by Amazentis SA at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF:plasma ratio (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.