Cranberry Juice and Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT01295684|
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Other: Cranberry juice Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
- Change in biomarkers of cardiovascular disease and polyphenol absorption [ Time Frame: Days 1&2; Days 27&28; Days 55&56 ]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 ]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 ]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 ]A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|