Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress

June 4, 2014 updated by: Washington State University

Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action

The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.

Study Overview

Detailed Description

Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Pullman, Washington, United States, 99164
        • WSU Bioactives Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men & women; aged 18-35 years
  • BMI: 19-25 kg/m2

Exclusion Criteria:

  • Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
  • Had major gastrointestinal surgery or on prescription or surgical treatment
  • Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
  • Regularly smoked in the previous 6 months
  • On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
  • Risk factors for AIDS or known HIV positive status
  • Pregnant or lactating
  • High intake of chocolate or similar high polyphenol foods
  • Regular intake of vitamin and polyphenol supplements
  • Drug and alcohol misuse
  • Currently participating or had participated in another clinical study during the previous 3 weeks
  • Donated blood in the previous 3 weeks
  • Exercise more than 3 times/week for longer than 45 min each time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Low Calorie Cranberry Juice Cocktail
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
ACTIVE_COMPARATOR: Cranberry Extract Beverage
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
PLACEBO_COMPARATOR: Non-Cranberry Beverage
Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Superoxide Dismutase (SOD) Activity in Red Blood Cells
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Glutathione Peroxidase (GPx) Activity in Red Blood Cells
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
C-Reactive Protein (CRP) Concentrations in Plamsa
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Nitric Oxide (NO) Concentrations in Plamsa
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-1alpha (IL-1a) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-1beta (IL-1b) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-2 (IL-2) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-4 (IL-4) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-6 (IL-6) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-8 (IL-8) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interleukin-10 (IL-10) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Interferon-gamma (IFN-y) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
0, 2, 4, 8, 24 h
Urinary Anti-bacteria Adhesion Activity
Time Frame: 0, 3, 6, 9, 12, 24 h
0, 3, 6, 9, 12, 24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Boon P Chew, PhD, Washington State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

January 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Low Calorie Cranberry Juice Cocktail

Subscribe