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OpenTrials
Completed

NCT Number: NCT01295684

Cranberry Juice and Cardiovascular Disease

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry juice

Other

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

Placebo

Other

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

Primary outcomes

  1. Change in biomarkers of cardiovascular disease and polyphenol absorption

    Time frame: Days 1&2; Days 27&28; Days 55&56

    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 outcomes

  1. Change from baseline in systolic and diastolic blood pressure

    Time frame: Days 1, 28, and 56

    Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points.

  2. Change in urine metabolomics and adhesion analysis

    Time frame: Days 1 & 56

    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.

  3. Change in fecal microbiota

    Time frame: Days 1 & 56

    A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.

Sponsors and collaborators

Lead sponsor

United States Department of Agriculture (USDA)

Fed

Collaborators

  • Ocean Spray, Inc.

Registry information

Official study title

The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 14, 2011
Registry last updated
Feb 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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