Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
Not Applicable
Completed
- Conditions
- HealthyHealthy Aging
- Interventions
- Dietary Supplement: Mitopure™ (Proprietary Urolithin A)Dietary Supplement: Pomegranate Juice
- Registration Number
- NCT04160312
- Lead Sponsor
- Amazentis SA
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mitopure™ (Proprietary Urolithin A) Mitopure™ (Proprietary Urolithin A) Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) Pomegranate Juice Pomegranate Juice 100% Pomegranate juice equivalent to a glass of juice
- Primary Outcome Measures
Name Time Method 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
Name Time Method Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels. 1 day 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 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 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 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 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 in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale 1 day Scale, of 1 to 5 where 1 is dislike extremely and 5 is like extremely
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. 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). 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 blood biochemistry metabolic profile as assessed via lipid profile in plasma. 2 days
Trial Locations
- Locations (1)
Atlantia Food Clinical Trials CRO (Northwestern University campus)
🇺🇸Chicago, Illinois, United States