Clinical trial NCT04160312: Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Healthy Aging
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2019-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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;

Primary outcomes:
measure: 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.
timeFrame: 2 days
Secondary outcomes:
measure: Absolute change from T0 to T+24 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels
timeFrame: 2 days
measure: Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels.
timeFrame: 1 day
measure: Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels.
timeFrame: 1 day
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire.
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F).
timeFrame: 2 days
measure: 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.
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry
timeFrame: 2 days
measure: Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma.
timeFrame: 2 days
measure: Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials CRO (Northwestern University campus)
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Ali Keshavarzian, MD
role: PRINCIPAL_INVESTIGATOR
References: