Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults (NOURISH)

Amazentis

Status: Completed

Conditions: Healthy; Healthy Aging

Treatments: Dietary Supplement: Pomegranate Juice; Dietary Supplement: Mitopure™ (Proprietary Urolithin A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04160312

AFCRO-110 / 19.01.AMZ

Details and patient eligibility

About

This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice

Enrollment: 100 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 clinical research team;
3. Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
4. Have given voluntary, written, informed consent to participant in the study;

Exclusion criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
2. Alcohol or drug abuse within the last 6 months;
3. Volunteers who plan to donate blood during the study or within 30 days of completing the study;
4. Subject has a known allergy to the test material's active or inactive ingredients;
5. Subjects with unstable medical conditions;
6. Clinically significant abnormal laboratory results at screening;
7. Participation in a clinical research trial within 30 days prior to randomization;
8. Allergy or sensitivity to study ingredients; lactose intolerance.
9. Individuals who are cognitively impaired and/or who are unable to give informed consent;
10. 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.
11. Has taken antibiotics within the previous 30 days;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Mitopure™ (Proprietary Urolithin A)

Experimental group

Description:

Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)

Treatment:

Dietary Supplement: Mitopure™ (Proprietary Urolithin A)

Pomegranate Juice

Experimental group

Description:

100% Pomegranate juice equivalent to a glass of juice

Treatment:

Dietary Supplement: Pomegranate Juice