RecruitingNot ApplicableNCT04985630

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

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)

Sponsor

Amazentis SA

Enrollment

250 participants

Start Date

Aug 30, 2021

Study Type

INTERVENTIONAL

Conditions

Healthy Healthy Aging Healthy Diet

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Males and females 18 to 80 years of age;
Is in general good health, as determined by the research team;
Willingness to consume the investigation product, complete questionnaires and to complete the study;
Have given voluntary, electronic, informed consent to be a participant in the study.

Exclusion Criteria9

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
Volunteers who plan to donate blood during the study or within 30 days of completing the study;
Subject has a known allergy to the test material's active or inactive ingredients;
Subjects with unstable medical conditions;
Participation in a clinical research trial within 30 days prior to randomization;
Allergy or sensitivity to study ingredients;
Individuals who are cognitively impaired and/or who are unable to give informed consent;
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;
Has taken antibiotics within the previous 30 days.

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