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

NCT ID: NCT03713164

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2018-09-01

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).

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pomegranate Juice (PJ)

single dose of 8oz Pomegranate Juice (PJ)

Group Type: ACTIVE_COMPARATOR

Pomegranate Juice

Intervention Type: DIETARY_SUPPLEMENT

Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.

Ellagic Acid (EA)

500 mg Ellagic Acid (EA) capsules

Group Type: ACTIVE_COMPARATOR

Ellagic Acid

Intervention Type: DIETARY_SUPPLEMENT

Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.

Interventions

Pomegranate Juice

Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.

Intervention Type: DIETARY_SUPPLEMENT

Ellagic Acid

Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PJ; EA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Zhaoping Li

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoping Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Human Nutrition, 900 Veteran Ave.

Los Angeles, California, United States

Countries

United States

Other Identifiers

17-001629

Identifier Type: -

Identifier Source: org_study_id