Cranberry Juice and Cardiovascular Disease

The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: Placebo; Other: Cranberry juice

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA's Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: United States Department of Agriculture (USDA)
• Collaborators: Ocean Spray, Inc.
• Investigators: Principal Investigator: Janet Novotny, Ph. D., USDA Beltsville Human Nutrition Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 14, 2011
• Last Update Submitted That Met QC Criteria: February 11, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: cardiovascular; polyphenol; cranberry; adhesion
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2010-085