Cranberry Juice and Cardiovascular Disease

NCT ID: NCT01295684

Last Updated: 2011-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

placebo

Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage

Cranberry Juice

Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day.

Group Type: EXPERIMENTAL

Cranberry juice

Intervention Type: OTHER

base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day

Interventions

Cranberry juice

base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day

Intervention Type: OTHER

Placebo

base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ocean Spray, Inc.

INDUSTRY

Sponsor Role: collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role: lead

Responsible Party

USDA

Principal Investigators

Janet Novotny, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

References

Novotny JA, Baer DJ, Khoo C, Gebauer SK, Charron CS. Cranberry juice consumption lowers markers of cardiometabolic risk, including blood pressure and circulating C-reactive protein, triglyceride, and glucose concentrations in adults. J Nutr. 2015 Jun;145(6):1185-93. doi: 10.3945/jn.114.203190. Epub 2015 Apr 22.

Reference Type: DERIVED

PMID: 25904733 (View on PubMed)

Other Identifiers

2010-085

Identifier Type: -

Identifier Source: org_study_id