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

Open-labelled Study to Validate Home-based Use of a Health and Wellness Kit (The Mitopure Challenge) to Detect Levels of Urolithin A in Dried Blood Spots After Intake of Mitopure (Proprietary Urolithin A)

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Healthy Aging; Healthy Diet
• Intervention / Treatment: Dietary supplement: Mitopure; Dietary supplement: Pomegranate Juice

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Faitg, PhD; Phone Number: +41215521272; Email: jfaitg@amazentis.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94111
      • Recruiting
      • Amazentis USA
      • Contact: Anurag Singh, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Dietary supplement: Mitopure; Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A); Dietary supplement: Pomegranate Juice; 100% Pomegranate juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure/rejection rate (% of the samples) collected at home by participants.	Acceptability target goal is to hit 80% of analyzed samples	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amazentis SA
• Investigators: Principal Investigator: Anurag Singh, MD, PhD, Amazentis SA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21.02.AMZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No