Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cranberry Juice and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01295684
First received: May 11, 2010
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295684

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

No publications provided

Responsible Party: Janet Novotny, Ph. D., USDA
ClinicalTrials.gov Identifier: NCT01295684     History of Changes
Other Study ID Numbers: 2010-085
Study First Received: May 11, 2010
Last Updated: February 11, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014