Recruiting

Urolithin A

Sponsor:

Amazentis SA

Code:

NCT04985630

Conditions

Healthy Aging

Healthy

Healthy Diet

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Mitopure

Pomegranate Juice

Study Details

Brief summary:

Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.

Conditions

Healthy Aging

Healthy

Healthy Diet

Study ID

NCT04985630

Start date

Aug 30, 2021

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Males and females 18 to 80 years of age;
2. Is in general good health, as determined by the research team;
3. Willingness to consume the investigation product, complete questionnaires and to complete the study;
4. Have given voluntary, electronic, informed consent to be a participant in the study.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
2. Volunteers who plan to donate blood during the study or within 30 days of completing the study;
3. Subject has a known allergy to the test material's active or inactive ingredients;
4. Subjects with unstable medical conditions;
5. Participation in a clinical research trial within 30 days prior to randomization;
6. Allergy or sensitivity to study ingredients;
7. Individuals who are cognitively impaired and/or who are unable to give informed consent;
8. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject;
9. Has taken antibiotics within the previous 30 days.

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake

Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)

Interventions

Mitopure

Fruit flavored sachet containing fixed dose of Mitopureā„¢ (Proprietary Urolithin A)

Pomegranate Juice

100% Pomegranate juice

Primary outcome measure

  • Failure/rejection rate (% of the samples) collected at home by participants. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Amazentis USA

Recruiting

San Francisco, California, United States, 94111

More Information

Sponsor

Amazentis SA

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amazentis SA on 2025-09-08.