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| Name | Class |
|---|---|
| Universidad CatĂłlica San Antonio de Murcia | OTHER |
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Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. However, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. The investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be administered. The investigators will analyze blood and urine samples using UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate extract | Experimental | The same group will consume the two types of pomegranate extract (crossover study). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate extract | Dietary Supplement | Crossover study: The group will consume the pomegranate extract with low punicalagin:EA ratio (PE-1). After 2 weeks of washout, the same group will also consume the other extract with high punicalagin: EA ratio (PE-2). |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour pharmacokinetics of ellagic acid in plasma | Determination of pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for ellagic acid and derived metabolites. | Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 72-h accumulation of urolithins in urine | Production of urolithins depending on the punicalagin:free ellagic acid ratio. | Changes from baseline at 24, 48 and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Juan Carlos EspĂn, PhD | National Research Council (CEBAS-CSIC, Murcia, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM (San Antonio Catholic University from Murcia) | Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| C000712310 | pomegranate fruit rind |
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| Pomegranate extract | Dietary Supplement | Crossover study: The group will consume the pomegranate extract with high punicalagin:EA ratio (PE-2) after 2 weeks of washout. The same group will also consume the other extract with low punicalagin: EA ratio (PE-1). |
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