Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker of cranberry intake. We hypothesize the consumption of this cranberry beverage in a progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy, nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular, endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women in this age range are particularly vulnerable to urinary tract infection. Volunteers will be asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot urine samples each will be collected from subjects during the study. Urinary PAC-A2 concentration will then be determined to validate if it can serve as a marker of compliance of cranberry juice consumption.
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study|
- Proanthocyanidin A2 [ Time Frame: 24-hour urine and morning spot urine ] [ Designated as safety issue: No ]proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.
|Study Start Date:||September 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: cranberry juice
27% cranberry juice
Other: cranberry juice
27% cranberry juice
People who frequently eat whole grains, fruits and berries, vegetables, beans and legumes, nuts, seeds, cocoa, tea, wine, and fruit or vegetable juices may have decreased risk of diseases. It is believed that some of these health benefits are due to phytochemicals present in these foods and beverages. Phytochemicals are nutrients that are naturally present in plant-based foods and beverages. Recently, cranberry containing foods and beverages are believed to prevent urinary tract infection. However, how cranberry decrease urinary tract infection is not very clear. To better understand how phytochemicals in cranberries may benefit health, we want to learn how they are absorbed and eliminated from the body. Thus, the purpose of the main study is to see whether we can measure phytochemicals from cranberries in health volunteers after they drink cranberry juice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687114
|United States, Massachusetts|
|Jean Mayer USDA Human Nutrition Research Center on Aging|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Oliver Chen, PhD||Tufts University|