Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults

Amazentis SA100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

100

Conditions

Healthy Healthy Aging

Interventions

Mitopure™ (Proprietary Urolithin A)DIETARY_SUPPLEMENT

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

Pomegranate JuiceDIETARY_SUPPLEMENT

100% Pomegranate juice (approximately 1 glass equivalent)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Atlantia Food Clinical Trials CRO (Northwestern University campus)

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 days

Secondary Outcomes

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

Time frame: 2 days

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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 2 days

Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA aglycone (parent) plasma levels

Time frame: 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 sulfate plasma levels

Time frame: 2 days

Change in AUC from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels

Time frame: 2 days

Data from ClinicalTrials.gov

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