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

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray Cranberries, Inc.
Information provided by (Responsible Party):
Washington State University
ClinicalTrials.gov Identifier:
NCT01780922
First received: January 29, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Inflammation
Other: Low Calorie Cranberry Juice Cocktail
Other: Cranberry Extract Beverage
Other: Non-Cranberry Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action

Further study details as provided by Washington State University:

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

Enrollment: 12
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Calorie Cranberry Juice Cocktail
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Other: Low Calorie Cranberry Juice Cocktail
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
Other: Cranberry Extract Beverage
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
Other: Non-Cranberry Beverage
Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01780922

Locations
United States, Washington
WSU Bioactives Research Lab
Pullman, Washington, United States, 99164
Sponsors and Collaborators
Washington State University
Ocean Spray Cranberries, Inc.
Investigators
Principal Investigator: Boon P Chew, PhD Washington State University
  More Information

No publications provided

Responsible Party: Washington State University
ClinicalTrials.gov Identifier: NCT01780922     History of Changes
Other Study ID Numbers: 11369
Study First Received: January 29, 2013
Results First Received: April 22, 2014
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington State University:
Inflammation
Oxidative Stress
Vaccinium macrocarpon

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014