RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.

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)

Quick Facts

Study Start:2021-08-30

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04985630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Julie Faitg, PhD

CONTACT

+41215521272

jfaitg@amazentis.com

Principal Investigator

Anurag Singh, MD, PhD

PRINCIPAL_INVESTIGATOR

Amazentis SA

Study Locations (Sites)

Amazentis USA

San Francisco, California, 94111

United States

Collaborators and Investigators

Sponsor: Amazentis SA

Anurag Singh, MD, PhD, PRINCIPAL_INVESTIGATOR, Amazentis SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-30

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-08-30

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Healthy Aging
Healthy
Healthy Diet