Cranberry Juice and Cardiovascular Disease
Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease|
- Change in biomarkers of cardiovascular disease and polyphenol absorption [ Time Frame: Days 1&2; Days 27&28; Days 55&56 ] [ Designated as safety issue: No ]A blood lipid panel will include plasma total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apo A-1, Apo A-II, Apo B, Lpa. Inflammatory markers (IL-6, IL-10, IL-1-alpha, CRP, TNF-alpha, fibrinogen, iCAM) will be determined by ELISA. Serum will be analyzed for polyphenol concentration.
- Change from baseline in systolic and diastolic blood pressure [ Time Frame: Days 1, 28, and 56 ] [ Designated as safety issue: No ]Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points.
- Change in urine metabolomics and adhesion analysis [ Time Frame: Days 1 & 56 ] [ Designated as safety issue: No ]Urine (24 hour cumulative and spot)will be collected at the beginning and end of each treatment period and provided to Ocean Spray for metabolomics and adhesion analysis.
- Change in fecal microbiota [ Time Frame: Days 1 & 56 ] [ Designated as safety issue: No ]A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.
|Study Start Date:||September 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.
base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
Experimental: Cranberry Juice
Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day.
Other: Cranberry juice
base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295684
|United States, Maryland|
|USDA's Beltsville Human Nutrition Research Center|
|Beltsville, Maryland, United States, 20705|
|Principal Investigator:||Janet Novotny, Ph. D.||USDA Beltsville Human Nutrition Research Center|