Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults

NCT04160312 | Completed

• 1 other identifier: AFCRO-110 / 19.01.AMZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels.

  2 days

Secondary Outcomes (17)

• Absolute change from T0 to T+24 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels

  2 days

• Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels.

  1 day

• Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels.

  1 day

• Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA glucuronide levels

  2 days

• Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA aglycone (parent) plasma levels

  2 days

Study Arms (2)

Mitopure™ (Proprietary Urolithin A)

EXPERIMENTAL

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

Dietary Supplement: Mitopure™ (Proprietary Urolithin A)

Pomegranate Juice

EXPERIMENTAL

100% Pomegranate juice equivalent to a glass of juice

Dietary Supplement: Pomegranate Juice

Interventions

Mitopure™ (Proprietary Urolithin A) DIETARY_SUPPLEMENT

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

Mitopure™ (Proprietary Urolithin A)

Pomegranate Juice DIETARY_SUPPLEMENT

100% Pomegranate juice (approximately 1 glass equivalent)

Pomegranate Juice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 to 80 years of age;
• Is in general good health, as determined by the clinical research team;
• Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
• Have given voluntary, written, informed consent to participant in the study;

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
• Alcohol or drug abuse within the last 6 months;
• 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;
• Clinically significant abnormal laboratory results at screening;
• Participation in a clinical research trial within 30 days prior to randomization;
• Allergy or sensitivity to study ingredients; lactose intolerance.
• 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;

Sponsors & Collaborators

• Amazentis SA: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials CRO (Northwestern University campus)

Chicago, Illinois, 60611, United States

Location

Study Officials

• Ali Keshavarzian, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: November 8, 2019
• Primary Completion: February 29, 2020
• Study Completion: March 31, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)