Cranberry Juice and Cardiovascular Disease - Full Text View

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:

MedlinePlus related topics: Adhesions

U.S. FDA Resources

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

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 May 23, 2013