Cranberry Juice and Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: Cranberry juice
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 to 65 years of age BMI 20 to 38 kg/m2 Exclusion Criteria: history of bariatric or certain other surgeries related to weight control kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes Type 2 diabetes or use of glucose-lowering medication Have a fasting blood sugar greater than 126 mg/dL LDL-cholesterol less than 130 mg/dL fasting triglycerides greater than 300 mg/dL use of cholesterol-lowering medication or supplements use of blood pressure-lowering medication smoking or use of other tobacco products (within 6 months prior to the start of the study) unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study use antibiotics during the study,or for 3 weeks prior to starting the study. history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) weight loss of >/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months inability to eat cranberries inability or unwillingness to give informed consent or communicate with study staff self-reported history of alcohol or substance abuse within the past 12 months and/or are currently in treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion) other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage. | Other: Placebo<br>* base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage<br>|
| Experimental: Cranberry Juice<br>Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day. | Other: Cranberry juice<br>* base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cranberry, cardiovascular, adhesion, polyphenol