Healthy Clinical Trial
Official title:
Exploratory Study to Determine the Bioavailability and Metabolism of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid
Verified date | September 2019 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 19 |
Est. completion date | September 1, 2018 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Center for Human Nutrition, 900 Veteran Ave. | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare Bioavailability of EA | Bioavailability of EA | 1 day |
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