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The Effects of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid on Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT03713164
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Pomegranate Juice Dietary Supplement: Ellagic Acid Phase 1 Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploratory Study to Determine the Bioavailability and Metabolism of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : September 1, 2018

Arm Intervention/treatment
Active Comparator: Pomegranate Juice (PJ)
single dose of 8oz Pomegranate Juice (PJ)
Dietary Supplement: Pomegranate Juice
Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.
Other Name: PJ

Active Comparator: Ellagic Acid (EA)
500 mg Ellagic Acid (EA) capsules
Dietary Supplement: Ellagic Acid
Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.
Other Name: EA




Primary Outcome Measures :
  1. Compare Bioavailability of EA [ Time Frame: 1 day ]
    Bioavailability of EA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713164


Locations
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United States, California
UCLA Center for Human Nutrition, 900 Veteran Ave.
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li, MD, PhD University of California, Los Angeles

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Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03713164     History of Changes
Other Study ID Numbers: 17-001629
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No