Effects of Cranberry Juice on Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Cranberry Juice on Cardiovascular Risk Factors in a Placebo-controlled Crossover Trial

Conditions
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Cardiovascular Disease Risk Factors

Intervention / Treatment
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* Dietary Supplement: Cranberry Juice Beverage
* Dietary Supplement: Placebo Beverage


Participation Criteria
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Eligibility Criteria
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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: Systolic blood pressure 120-159 mmHg Diastolic blood pressure 80-99 mmHg Exclusion Criteria: History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within previous 6 months are provided) History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening) Stage II hypertension (blood pressure ≥ 160/100 mmHg) Lactation, pregnancy, or desire to become pregnant during the study Unwillingness to discontinue nutritional supplements, herbs, or vitamins unless approved by investigator Use of medications/supplements for elevated lipids, blood pressure, or glucose Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication Conditions requiring the use of steroids Unwillingness to refrain from blood donation prior to and during the study Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator Allergy or sensitivity to cranberry juice or any ingredient in the study beverages

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranberry Juice Beverage<br>16 ounces of 54% cranberry juice cocktail | Dietary Supplement: Cranberry Juice Beverage<br>* 16 ounces of 54% cranberry juice cocktail<br>|
| Placebo Comparator: Placebo Beverage<br>Color, calorie, and taste matched beverage without cranberry bioactives | Dietary Supplement: Placebo Beverage<br>* Color, calorie, and taste matched beverage without cranberry bioactives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranberries, blood pressure, cholesterol, SphygmoCor