Clinical trial NCT03713164: The Effects of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid on Healthy Male Subjects
Official title: Exploratory Study to Determine the Bioavailability and Metabolism of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Compare Bioavailability of EA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, 900 Veteran Ave.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: