Status:
COMPLETED
Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body
Lead Sponsor:
University of California, Los Angeles
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
This study is comparing the quantity of active metabolites from consuming pomegranate juice in three different preparations. People who participate in this study will come in to the Center for a scree...
Detailed Description
Pomegranate (Punica granatum L.) fruits are widely consumed as pomegranate juice (PJ), and their health benefits have been studied extensively in animals and humans (1-6). The pomegranate fruit is a r...
Eligibility Criteria
Inclusion
- Male or female \>20 and \< 45 years of age at the time the consent form is signed.
- Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Exclusion
- Any subject who is eating more than 4 servings per day of fruits and vegetables, taking vitamin supplements or taking any antibiotics or other medication or dietary supplement which interfere with the absorption of polyphenols.
- Any subjects with a history of gastrointestinal surgery (except for appendectomy), diabetes mellitus, or other serious medical condition, such as chronic hepatitis 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 BP \>160mmHg, diastolic BP\>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease corrected with medication to normal laboratory values) as indicated by medical history or routine physical examination.
- Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery
- Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months.
- Known HIV positive.
- Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
- Currently receiving systemic chemotherapy and/or radiotherapy.
- Active bleeding.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject who is allergic to soy protein.
- In the opinion of the study investigator has a risk of non-compliance with study procedures, or can not read, understand or complete study related materials.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02233478
Start Date
August 1 2014
End Date
January 1 2015
Last Update
September 19 2019
Active Locations (1)
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1
UCLA Center for Human Nutrition
Los Angeles, California, United States, 90095