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Cranberry Juice and Cardiovascular Disease

U

United States Department of Agriculture (USDA)

Status

Completed

Conditions

Cardiovascular Disease

Treatments

Other: Placebo
Other: Cranberry juice

Study type

Interventional

Funder types

Other U.S. Federal agency
Industry

Identifiers

NCT01295684
2010-085

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.
Treatment:
Other: Placebo
Cranberry Juice
Experimental group
Description:
Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day.
Treatment:
Other: Cranberry juice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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