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)
Verified date | July 2023 |
Source | Amazentis SA |
Contact | Julie Faitg, PhD |
Phone | +41215521272 |
jfaitg[@]amazentis.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Amazentis USA | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Amazentis SA |
United States,
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
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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