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Cranberry Juice and Cardiovascular Disease

This study has been completed.
Ocean Spray, Inc.
Information provided by:
USDA Beltsville Human Nutrition Research Center Identifier:
First received: May 11, 2010
Last updated: February 11, 2011
Last verified: February 2011
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.

Condition Intervention
Cardiovascular Disease
Other: Cranberry juice
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in biomarkers of cardiovascular disease and polyphenol absorption [ Time Frame: 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:
  • Change from baseline in systolic and diastolic blood pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Estimated Enrollment: 60
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01295684

United States, Maryland
USDA's Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
United States Department of Agriculture (USDA)
Ocean Spray, Inc.
Principal Investigator: Janet Novotny, Ph. D. USDA Beltsville Human Nutrition Research Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Janet Novotny, Ph. D., USDA Identifier: NCT01295684     History of Changes
Other Study ID Numbers: 2010-085
Study First Received: May 11, 2010
Last Updated: February 11, 2011

Keywords provided by USDA Beltsville Human Nutrition Research Center:

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on May 25, 2017