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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

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 13, 2019
Last Update Posted Date April 10, 2020
Actual Study Start Date  ICMJE November 8, 2019
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • 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 ]
  • To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population [ Time Frame: 2 days ]
  • Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer [ Time Frame: 2 days ]
  • Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test [ Time Frame: 2 days ]
  • 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.
  • 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).
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Healthy Aging
Intervention  ICMJE
  • Dietary Supplement: Mitopure™ (Proprietary Urolithin A)
    Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
  • Dietary Supplement: Pomegranate Juice
    100% Pomegranate juice (approximately 1 glass equivalent)
Study Arms  ICMJE
  • Experimental: Mitopure™ (Proprietary Urolithin A)
    Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
    Intervention: Dietary Supplement: Mitopure™ (Proprietary Urolithin A)
  • Experimental: Pomegranate Juice
    100% Pomegranate juice equivalent to a glass of juice
    Intervention: Dietary Supplement: Pomegranate Juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04160312
Other Study ID Numbers  ICMJE AFCRO-110 / 19.01.AMZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Amazentis SA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amazentis SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Atlantia Food Clinical Trials
Investigators  ICMJE
Principal Investigator: Ali Keshavarzian, MD Rush University Medical Center
PRS Account Amazentis SA
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP