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

Open-labelled, Crossover and Randomized Study With Mitopure™ (Proprietary Urolithin A) Dietary Supplementation Compared to Pomegranate Juice Intake: A Bioavailability Study in Healthy Adults (NOURISH)

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 Overview

• Status: Completed
• Conditions: Healthy; Healthy Aging
• Intervention / Treatment: Dietary supplement: Mitopure™ (Proprietary Urolithin A); Dietary supplement: Pomegranate Juice

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Atlantia Food Clinical Trials CRO (Northwestern University campus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitopure™ (Proprietary Urolithin A); Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)	Dietary supplement: Mitopure™ (Proprietary Urolithin A); Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
Experimental: Pomegranate Juice; 100% Pomegranate juice equivalent to a glass of juice	Dietary supplement: Pomegranate Juice; 100% Pomegranate juice (approximately 1 glass equivalent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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		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		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		2 days
To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population		2 days
Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer		2 days
Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test		2 days
Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire.	Questionnaire consists of questions that provide information on the physical activity in the last 7 days. Activities include total of duration and frequency from walking, moderate activity and severe physical activity. Accordingly,there are 3 activity levels: Inactive,minimal active and very active.The lowest level of physical activity is inactive and the highest level of physical activity is very active.	2 days
Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F).	The scale consists of 18 items relating to the subjective experience of fatigue. Scores fall between 0 (not fatigued at all) and 100 (extremely fatigued).	2 days
Differences between UA producers and non-producers at baseline for gut microbiome. Fecal samples will be used to extract DNA and shotgun sequencing will be performed to assess global microbiome differences at the species level.		2 days
Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry		2 days
Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma.		2 days
Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale	Scale, of 1 to 5 where 1 is dislike extremely and 5 is like extremely	1 day

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AFCRO-110 / 19.01.AMZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No