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

Not Applicable

Recruiting

• Conditions: Healthy Diet; Healthy; Healthy Aging

• Registration Number: NCT04985630
• Lead Sponsor: Amazentis SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-08-02
• Study Start: 2021-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Amazentis USA; 🇺🇸 San Francisco, California, United States