Clinical trial NCT04985630: The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Healthy
Healthy Diet
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Failure/rejection rate (% of the samples) collected at home by participants.
timeFrame: 4 weeks
Secondary outcomes:
measure: Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: Validation of a health questionnaire on participants health status
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Amazentis USA
state: California
Study officials:
affiliation: Amazentis SA
name: Anurag Singh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.