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| Name | Class |
|---|---|
| Ocean Spray Cranberries, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effects of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. The investigators hypothesize that the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure and arterial health, as well as LDL-C and HDL function.
The investigators propose to conduct a 2-period randomized, crossover, placebo-controlled study to evaluate the effect of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. Eligibility requires non-smoking men and women to be 30 to 65 years of age with BMI greater than or equal to 18 and less than or equal to 39, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, triglycerides below 350 mg/dL, and have systolic blood pressure of 120 to 159 mmHg and/or diastolic blood pressure of 80 to 99 mmHg. Subjects will undergo randomized treatments including 500 mL/d cranberry juice beverage and 500 mL/d of a color and taste matched placebo beverage. The two 8 to 12 week treatment periods will be separated by an 8 week washout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry Juice Beverage | Experimental | 16 ounces of 54% cranberry juice cocktail |
|
| Placebo Beverage | Placebo Comparator | Color, calorie, and taste matched beverage without cranberry bioactives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranberry Juice Beverage | Dietary Supplement | 16 ounces of 54% cranberry juice cocktail |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Blood Pressure | Aortic (central) blood pressure measured using the SphygmoCor system | Change from baseline after 8 week treatments with cranberry and placebo |
| Peripheral Blood Pressure | Peripheral blood pressure measured using the SphygmoCor system | Change from baseline after 8 week treatments with cranberry and placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efflux capacity of HDL | Ability to carry out reverse cholesterol transport measured using in vitro assay | Change from baseline after 8 week treatments with cranberry and placebo |
| Augmentation Index |
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Inclusion Criteria:
Men and women 30-65 years of age
BMI ≥ 18 and ≤ 39 kg/m^2
Total cholesterol below 273 mg/dL for men and below 284 mg/dL for women
Triglycerides below 350 mg/dL
Non-smokers
At least one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny Kris-Etherton, PhD, RD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State CRC | University Park | Pennsylvania | 16802 | United States |
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| Placebo Beverage | Dietary Supplement | Color, calorie, and taste matched beverage without cranberry bioactives |
|
Augmentation index measured using the SphygmoCor system
| Change from baseline after 8 week treatments with cranberry and placebo |
| Pulse Wave Velocity | Pulse wave velocity measured using the SphygmoCor system | Change from baseline after 8 week treatments with cranberry and placebo |
| LDL-C | LDL-C values calculated using the Friedewald equation | Change from baseline after 8 week treatments with cranberry and placebo |
| LDL Particle Size | LDL particle size measured using a Vertical Auto Profile (VAP) Test | Change from baseline after 8 week treatments with cranberry and placebo |
| Total Cholesterol | Total cholesterol values determined by enzymatic procedures | Change from baseline after 8 week treatments with cranberry and placebo |
| Triglycerides | Triglyceride values determined using enzymatic procedures | Change from baseline after 8 week treatments with cranberry and placebo |
| HDL-C | HDL-C will be estimated according to the modified heparin-manganese procedure | Change from baseline after 8 week treatments with cranberry and placebo |
| Oxidized LDL (oxLDL) | Plasma concentrations of oxLDL will be measured using ELISA kits | Change from baseline after 8 week treatments with cranberry and placebo |
| Malondialdehyde (MDA) | MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay | Change from baseline after 8 week treatments with cranberry and placebo |
| High Sensitivity C Reactive Protein (hs-CRP) | hs-CRP will be measured by latex-enhanced immunonephelometry | Change from baseline after 8 week treatments with cranberry and placebo |
| 24-hr Ambulatory Blood Pressure | Change from baseline after 8 week treatments with cranberry and placebo |