Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809900
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : December 2, 2009
Information provided by:
Tufts University

Brief Summary:
This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice.

Condition or disease Intervention/treatment
Bioavailability Cardiovascular Disease Dietary Supplement: Experimental

Detailed Description:

Little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins consumed in amounts relevant to usual dietary intakes. Thus, we hypothesize that anthocyanins from a single oral dose of cranberry juice will be absorbed quickly and can be measured in the circulation and urine within 2-4 h. Further, these anthocyanins will undergo a degree of metabolism but will circulate as well as be removed from blood as both parent compounds and metabolic products.

This research proposal is submitted as an independent sub-study of an existing project, "Effects of Cranberry Juice on Endothelial Function in Patients with Coronary Artery Disease", conducted by Joseph A. Vita, MD at the Boston University School of Medicine and sponsored by Ocean Spray Cranberries, Inc.

This study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease who will receive a single dose of 480 mL cranberry juice.

To test the hypotheses of the study to be conducted at HNRCA Tufts, we will utilize blood and urine samples that are already collected and stored. We will separate and analyze anthocyanins in these samples by HPLC and determine the pharmacokinetics of relevant anthocyanins.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Official Title: Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry (Vaccinium Macrocarpon)Consumption
Study Start Date : June 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Group/Cohort Intervention/treatment
Dietary Supplement
Cranberry Juice Consumption
Dietary Supplement: Experimental
Administration of of 480 mL cranberry juice
Other Name: Cranberry Juice

Primary Outcome Measures :
  1. Anthocyanin levels in plasma and urine [ Time Frame: 0, 2, and 4 hours ]

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease

Inclusion Criteria:

  • Stable CAD Patients
  • Men & postmenopausal women
  • Aged 21-80 years
  • All Ethnic Groups
  • English Language

Exclusion Criteria:

  • Subjects with heart failure are not eligible for participation in this study.
  • Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
  • Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
  • Regular use of oral steroids
  • Cigarette smoking and/or nicotine replacement use
  • Regular daily intake of ≥ 2 alcoholic drinks
  • Illicit drug use
  • History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  • No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
  • Treatment with an investigational new drug within the last 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809900

United States, Massachusetts
Jean Mayer USDA Human Nutrition Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Principal Investigator: Paul E. Milbury, Ph.D. Tufts University

Responsible Party: Paul E. Milbury, Ph.D., Tufts University Identifier: NCT00809900     History of Changes
Other Study ID Numbers: Tufts 7903
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2008

Additional relevant MeSH terms:
Cardiovascular Diseases