Cranberry Juice and Cardiovascular Disease

Cardiovascular Disease Clinical Trial

Official title:

The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295684
• Other study ID #: 2010-085
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: February 11, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Cranberry juice
base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day
• Placebo
base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage

Locations

Country	Name	City	State
United States	USDA's Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
United States Department of Agriculture (USDA)	Ocean Spray, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No