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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04985630
Other study ID # 21.02.AMZ
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mitopure
Fruit flavored sachet containing fixed dose of Mitopureā„¢ (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
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