An interventional study of Cranberry juice and Placebo in Cardiovascular Disease, sponsored by United States Department of Agriculture (USDA). Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-14.
Sponsored by United States Department of Agriculture (USDA) · Not applicable and Interventional
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →United States Department of Agriculture (USDA) is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.
Other: Placebo
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
base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
Change in biomarkers of cardiovascular disease and polyphenol absorption
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.
Time frame: Days 1&2; Days 27&28; Days 55&56
Change from baseline in systolic and diastolic blood pressure
Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points.
Time frame: Days 1, 28, and 56
Change in urine metabolomics and adhesion analysis
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.
Time frame: Days 1 & 56
Change in fecal microbiota
A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.
Time frame: Days 1 & 56
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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United States Department of Agriculture (USDA)