Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults

NCT ID: NCT04160312

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2020-03-31

Brief Summary

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

Conditions

Healthy; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mitopure™ (Proprietary Urolithin A)

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

Group Type: EXPERIMENTAL

Mitopure™ (Proprietary Urolithin A)

Intervention Type: DIETARY_SUPPLEMENT

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

Pomegranate Juice

100% Pomegranate juice equivalent to a glass of juice

Group Type: EXPERIMENTAL

Pomegranate Juice

Intervention Type: DIETARY_SUPPLEMENT

100% Pomegranate juice (approximately 1 glass equivalent)

Interventions

Mitopure™ (Proprietary Urolithin A)

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

Intervention Type: DIETARY_SUPPLEMENT

Pomegranate Juice

100% Pomegranate juice (approximately 1 glass equivalent)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Keshavarzian, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Atlantia Food Clinical Trials CRO (Northwestern University campus)

Chicago, Illinois, United States

Countries

United States

Other Identifiers

AFCRO-110 / 19.01.AMZ

Identifier Type: -

Identifier Source: org_study_id