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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitopure⢠(Proprietary Urolithin A) | Experimental | Fruit flavored food sachet containing fixed dose of Mitopure⢠(Proprietary Urolithin A) |
|
| Pomegranate Juice | Experimental | 100% Pomegranate juice equivalent to a glass of juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure⢠(Proprietary Urolithin A) | Dietary Supplement | Fruit flavored sachet containing fixed dose of Mitopure⢠(Proprietary Urolithin A) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Keshavarzian, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials CRO (Northwestern University campus) | Chicago | Illinois | 60611 | United States |
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| Pomegranate Juice | Dietary Supplement | 100% Pomegranate juice (approximately 1 glass equivalent) |
|
| 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 JAMARĀ® 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 |