Skip to main content
OpenTrials
Completed

NCT Number: NCT04160312

Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials CRO (Northwestern University campus)

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Mitopure™ (Proprietary Urolithin A)

Dietary Supplement

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

Pomegranate Juice

Dietary Supplement

100% Pomegranate juice (approximately 1 glass equivalent)

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.

    Time frame: 2 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Atlantia Food Clinical Trials

Registry information

Official study 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)

Acronym: NOURISH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.