The Effects of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid on Healthy Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/21/2018 |
| Start Date: | February 22, 2018 |
| End Date: | September 1, 2018 |
Exploratory Study to Determine the Bioavailability and Metabolism of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid
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).
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.
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.
Inclusion Criteria:
1. Age 18-45 years, male and any racial/ethnic group
2. Typically consume low fiber/polyphenol diet (beige diet)
3. Subjects must understand and sign the informed consent prior to participation
4. Subjects must be in generally good health
5. Subjects must be able and willing to comply with the requirements of the protocol.
Exclusion Criteria:
1. Eating a high fiber/polyphenol diet or taking any medication or dietary supplements
that interfere with the absorption of polyphenols.
2. History of gastrointestinal surgery, diabetes mellitus on medications, or other
serious medical condition, such as chronic hepatic or renal disease, bleeding
disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction,
coronary artery bypass graft, angioplasty within 6 months prior to screening, current
diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP
> 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative
abuse, or endocrine diseases (except thyroid disease requiring medication) as
indicated by medical history or routine physical examination.
3. Screening laboratory value outside of the laboratory normal range that is considered
clinically significant for study participation by the investigator.
4. Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
5. Allergy or sensitivity to pomegranate. Subjects will be excluded if there is a prior
history of such sensitivity. Since these foods are commonly eaten and allergies are
rare, subjects should be aware of this sensitivity prior to entering the study. In
addition, any subject with a history of allergy or anaphylaxis of any kind will be
excluded
6. Taking antibiotics or laxatives within the past 3 months
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