Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Healthy, Healthy Aging

Intervention / Treatment
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* Dietary Supplement: Mitopure™ (Proprietary Urolithin A)
* Dietary Supplement: Pomegranate Juice


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitopure™ (Proprietary Urolithin A)<br>Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) | Dietary Supplement: Mitopure™ (Proprietary Urolithin A)<br>* Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)<br>|
| Experimental: Pomegranate Juice<br>100% Pomegranate juice equivalent to a glass of juice | Dietary Supplement: Pomegranate Juice<br>* 100% Pomegranate juice (approximately 1 glass equivalent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 plasma levels. |  | 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. |  | 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 | 
| 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 | 
| 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 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. | 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. | 2 days | 
| Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F). | 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). | 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 between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma. |  | 2 days | 
| Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale | Scale, of 1 to 5 where 1 is dislike extremely and 5 is like extremely | 1 day |