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

Amazentis

Status: Enrolling

Conditions: Healthy; Healthy Diet; Healthy Aging

Treatments: Dietary Supplement: Pomegranate Juice; Dietary Supplement: Mitopure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04985630

21.02.AMZ

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake

Experimental group

Description:

Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)

Treatment:

Dietary Supplement: Mitopure

Dietary Supplement: Pomegranate Juice