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Cranberry Juice and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT01295684
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
USDA Beltsville Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Cranberry juice Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295684


Locations
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.
Investigators
Principal Investigator: Janet Novotny, Ph. D. USDA Beltsville Human Nutrition Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janet Novotny, Ph. D., USDA
ClinicalTrials.gov Identifier: NCT01295684     History of Changes
Other Study ID Numbers: 2010-085
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by USDA Beltsville Human Nutrition Research Center:
cranberry
cardiovascular
adhesion
polyphenol

Additional relevant MeSH terms:
Cardiovascular Diseases