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

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985630
• Other study ID #: 21.02.AMZ
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Amazentis SA
• Contact: Julie Faitg, PhD
• Phone: +41215521272
• Email: jfaitg[@]amazentis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Healthy Aging
• Healthy Diet

Intervention

Dietary Supplement:
• Mitopure
Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
• Pomegranate Juice
100% Pomegranate juice

Locations

Country	Name	City	State
United States	Amazentis USA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Amazentis SA

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure/rejection rate (% of the samples) collected at home by participants.	Acceptability target goal is to hit 80% of analyzed samples	4 weeks
Secondary	Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.		4 weeks
Secondary	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
Secondary	Validation of a health questionnaire on participants health status		4 weeks