Drug Interactions and Bioavailability of Cranberry - Full Text View

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00200759

Purpose

The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine.

Condition	Intervention	Phase
Healthy Drug Interactions	Drug: Cranberry juice and capsules	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:	Drug Interactions and Bioavailability of Cranberry

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	16
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2007

Detailed Description:

The use of cranberry (CB) juice and powders, both alone and in combination with conventional medicine, has become more common for the treatment of urinary tract infections (UTIs) and and other acute or chronic conditions. Cytochromes P450 enzymes are a group of proteins involved in metabolism of certain substances. A group of cytochrome P-450 (CYP) enzymes are extensively involved in drug metabolism. The pharmacokinetics of many drugs often vary considerably among individuals, largely because of variations in the expression of different cytochrome P-450 (CYP) enzymes in the liver and other tissues. Flavonoids are antioxidants that may have health benefits. The flavonoids may also be responsible for cranberry's effects on urinary tract infections.

To evaluate the drug interaction potential of cranberry, single doses of the three safe probe drugs alprazolam, dextromethorphan, and caffeine will be administered before and after a 14-day treatment period with cranberry powder. Changes in the pharmacokinetics of these probe drugs will indicate the degree of enzyme inhibition or induction. The key pharmacokinetic parameters for four major CB flavonoids will be estimated by following the plasma concentration versus time course of absorbed flavonoids and their excretion in urine. The area under the plasma concentration versus time curve (AUC), oral clearance (Clo), terminal elimination half-life (T1/2) and renal clearance (Clren) will be determined for: epicatechin, quercetin (total glycosides), procyanidin A2, and cyanidin-3-galactoside.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Females must have a negative urine pregnancy test prior to enrollment and must be committed to using barrier methods of birth control throughout the study.

Exclusion Criteria:

Clinically significant diseases or abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease. The exclusion criteria also includes 1) positive urine pregnancy test 2) The use of oral contraceptives 3) The lack of use of acceptable barrier methods of birth control unless abstinent
Use of any concomitant medication including herbal medications or a history of hypersensitivity to the medications used in the study
History of sensitivity to CB juice or products
Poor metabolizers of CYP2D6
Active smoking or use of caffeine-containing beverages for 2 weeks prior to and during the study
Inability to conform with dietary restrictions required for the study
Drug or alcohol abuse (more than 3 drinks/day)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200759

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer L. Donovan, PhD 843-792-5589 donovanj@musc.edu
Contact: Sterling Alexander 843-792-5449 alexans@musc.edu
Principal Investigator: Jennifer L. Donovan, PhD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Jennifer L Donovan, PhD

Medical University of South Carolina

More Information

Study ID Numbers:	R21 AT002073-01
Study First Received:	September 12, 2005
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00200759
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Vaccinium macrocarpon
Antioxidants
Drug Interactions

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009