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

NCT03713164 | Completed

• 1 other identifier: 17-001629
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Compare Bioavailability of EA

  Bioavailability of EA

  1 day

Study Arms (2)

Pomegranate Juice (PJ)

ACTIVE COMPARATOR

single dose of 8oz Pomegranate Juice (PJ)

Dietary Supplement: Pomegranate Juice

Ellagic Acid (EA)

ACTIVE COMPARATOR

500 mg Ellagic Acid (EA) capsules

Dietary Supplement: Ellagic Acid

Interventions

Pomegranate Juice DIETARY_SUPPLEMENT

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

Also known as: PJ

Pomegranate Juice (PJ)

Ellagic Acid DIETARY_SUPPLEMENT

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

Also known as: EA

Ellagic Acid (EA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years, male and any racial/ethnic group
• Typically consume low fiber/polyphenol diet (beige diet)
• Subjects must understand and sign the informed consent prior to participation
• Subjects must be in generally good health
• Subjects must be able and willing to comply with the requirements of the protocol.

You may not qualify if:

• Eating a high fiber/polyphenol diet or taking any medication or dietary supplements that interfere with the absorption of polyphenols.
• 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.
• Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
• Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
• 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
• Taking antibiotics or laxatives within the past 3 months

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 900 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Ellagic Acid

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: February 22, 2018
• Primary Completion: May 3, 2018
• Study Completion: September 1, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)