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| Name | Class |
|---|---|
| Ocean Spray, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage. |
|
| Cranberry Juice | Experimental | Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranberry juice | Other | base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1&2; Days 27&28; Days 55&56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1, 28, and 56 |
| Change in urine metabolomics and adhesion analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Novotny, Ph. D. | USDA Beltsville Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA's Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25904733 | Derived | Novotny JA, Baer DJ, Khoo C, Gebauer SK, Charron CS. Cranberry juice consumption lowers markers of cardiometabolic risk, including blood pressure and circulating C-reactive protein, triglyceride, and glucose concentrations in adults. J Nutr. 2015 Jun;145(6):1185-93. doi: 10.3945/jn.114.203190. Epub 2015 Apr 22. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage |
|
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.
| 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. | Days 1 & 56 |