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The purpose of this research study is to compare the extent of polyphenol absorption in the body in normal healthy male volunteers when consuming either pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates. Polyphenols are naturally occurring chemicals found in plant based food that serve to reduce inflammation and damage to cells. You will be asked to avoid foods rich in polyphenols including dark chocolate and cocoa products, dried herbs, berries, coffee, tea, flaxseeds, nuts (chestnut, hazelnut), olive and artichoke. Timed urine collections will be used to measure the metabolism of polyphenols through the presence and concentration of urolithin and ellagic acid metabolites. Additionally, it has been demonstrated in animal studies that fruits and vegetables, which are high in antioxidants and fiber, lead to improvement of gut health, inflammation and glucose tolerance. However, no information is available about the effect of ellagitanins on the gut microbiome (bacteria in the intestines).
Based on the limited knowledge about the difference in bacterial metabolism of a mixture of ellagitannins, punicalin, punicalagin and EA in PJ compared to pure EA leading to intestinal formation of different urolithins (urolithin A, B and iso-urolithin A), the objective of this study is to perform a cross over acute bioavailability study of 1-day consumption of either PJ or EA. Primary endpoint will be the formation and bioavailability of EA and urolithins. Secondary endpoints will be A) effect on the fecal microbiome and B) correlation of urolithin formation to the lipid/cholesterol status of the study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate Juice (PJ) | Active Comparator | single dose of 8oz Pomegranate Juice (PJ) |
|
| Ellagic Acid (EA) | Active Comparator | 500 mg Ellagic Acid (EA) capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate Juice | Dietary Supplement | Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Bioavailability of EA | Bioavailability of EA | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Females have been excluded from the study to reduce the variability in the endothelial measures and Nitric Oxide determinations being performed after administration of the pomegranate or ellagic acid capsules. Estrogen is known to affect these considerably so there would be no way to control these effects among female participants in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Human Nutrition, 900 Veteran Ave. | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D004610 | Ellagic Acid |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ellagic Acid | Dietary Supplement | Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates. |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |