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

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ClinicalTrials.gov Identifier: NCT04160312
Recruitment Status : Completed
First Posted : November 13, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Atlantia Food Clinical Trials
Information provided by (Responsible Party):
Amazentis SA

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Healthy Aging Dietary Supplement: Mitopure™ (Proprietary Urolithin A) Dietary Supplement: Pomegranate Juice Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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)
Actual Study Start Date : November 8, 2019
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : March 31, 2020
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population [ Time Frame: 2 days ]
  10. Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer [ Time Frame: 2 days ]
  11. Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test [ Time Frame: 2 days ]
  12. Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire. [ Time Frame: 2 days ]
    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.

  13. Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F). [ Time Frame: 2 days ]
    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).

  14. 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. [ Time Frame: 2 days ]
  15. Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry [ Time Frame: 2 days ]
  16. Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma. [ Time Frame: 2 days ]
  17. Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale [ Time Frame: 1 day ]
    Scale, of 1 to 5 where 1 is dislike extremely and 5 is like extremely


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160312


Locations
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United States, Illinois
Atlantia Food Clinical Trials CRO (Northwestern University campus)
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Amazentis SA
Atlantia Food Clinical Trials
Investigators
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Principal Investigator: Ali Keshavarzian, MD Rush University Medical Center
More Information
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Responsible Party: Amazentis SA
ClinicalTrials.gov Identifier: NCT04160312    
Other Study ID Numbers: AFCRO-110 / 19.01.AMZ
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No