Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry Consumption

This study has been completed.
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00809900
First received: December 15, 2008
Last updated: December 1, 2009
Last verified: December 2008
  Purpose

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 Intervention
Bioavailability
Cardiovascular Disease
Dietary Supplement: Experimental

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry (Vaccinium Macrocarpon)Consumption

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Anthocyanin levels in plasma and urine [ Time Frame: 0, 2, and 4 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dietary Supplement
Cranberry Juice Consumption
Dietary Supplement: Experimental
Administration of of 480 mL cranberry juice
Other Name: Cranberry Juice

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809900

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

No publications provided

Responsible Party: Paul E. Milbury, Ph.D., Tufts University
ClinicalTrials.gov Identifier: NCT00809900     History of Changes
Other Study ID Numbers: Tufts 7903
Study First Received: December 15, 2008
Last Updated: December 1, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014