Cranberry Juice and Cardiovascular Disease

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Placebo; Other: Cranberry juice

• Registration Number: NCT01295684
• Lead Sponsor: United States Department of Agriculture (USDA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Study First Submitted QC: 2011-02-11
• Last Update Submitted: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Posted: 2011-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.
Cranberry Juice	Cranberry juice	Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day.

Primary Outcome Measures

Name	Time	Method
Change in biomarkers of cardiovascular disease and polyphenol absorption	Days 1&2; Days 27&28; Days 55&56	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in systolic and diastolic blood pressure	Days 1, 28, and 56	Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points.
Change in urine metabolomics and adhesion analysis	Days 1 & 56	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.
Change in fecal microbiota	Days 1 & 56	A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.

Trial Locations

Locations (1)

USDA's Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States