The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots

NCT04985630 | Recruiting

• 1 other identifier: 21.02.AMZ
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Failure/rejection rate (% of the samples) collected at home by participants.

  Acceptability target goal is to hit 80% of analyzed samples

  4 weeks

Secondary Outcomes (3)

• Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.

  4 weeks

• Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge

  4 weeks

• Validation of a health questionnaire on participants health status

  4 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Dietary Supplement: Mitopure; Dietary Supplement: Pomegranate Juice

Interventions

Mitopure DIETARY_SUPPLEMENT

Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)

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

Pomegranate Juice DIETARY_SUPPLEMENT

100% Pomegranate juice

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
• Volunteers who plan to donate blood during the study or within 30 days of completing the study;
• Subject has a known allergy to the test material's active or inactive ingredients;
• Subjects with unstable medical conditions;
• Participation in a clinical research trial within 30 days prior to randomization;
• Allergy or sensitivity to study ingredients;
• Individuals who are cognitively impaired and/or who are unable to give informed consent;
• 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;
• Has taken antibiotics within the previous 30 days.

Sponsors & Collaborators

• Amazentis SA: lead

Study Sites (1)

Amazentis USA

San Francisco, California, 94111, United States

RECRUITING

Related Publications (1)

• Singh A, D'Amico D, Andreux PA, Dunngalvin G, Kern T, Blanco-Bose W, Auwerx J, Aebischer P, Rinsch C. Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. Eur J Clin Nutr. 2022 Feb;76(2):297-308. doi: 10.1038/s41430-021-00950-1. Epub 2021 Jun 11.

  PMID: 34117375 BACKGROUND

Study Officials

• Anurag Singh, MD, PhD

  Amazentis SA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Faitg, PhD

CONTACT

+41215521272; jfaitg@amazentis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 2, 2021
• Study Start: August 30, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)