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

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Calorie Cranberry Juice Cocktail
Cranberry Extract Beverage
Non-Cranberry Beverage
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Inflammation, Oxidative Stress, Vaccinium macrocarpon

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • WSU Bioactives Research Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Low Calorie Cranberry Juice Cocktail

Cranberry Extract Beverage

Non-Cranberry Beverage

Arm Description

Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes

Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes

Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 29, 2013
Last Updated
June 4, 2014
Sponsor
Washington State University
Collaborators
Ocean Spray Cranberries, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01780922
Brief Title
Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress
Official Title
Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University
Collaborators
Ocean Spray Cranberries, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation, Oxidative Stress, Vaccinium macrocarpon

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Calorie Cranberry Juice Cocktail
Arm Type
Active Comparator
Arm Description
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Arm Title
Cranberry Extract Beverage
Arm Type
Active Comparator
Arm Description
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Arm Title
Non-Cranberry Beverage
Arm Type
Placebo Comparator
Arm Description
Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Intervention Type
Other
Intervention Name(s)
Low Calorie Cranberry Juice Cocktail
Intervention Description
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
Intervention Type
Other
Intervention Name(s)
Cranberry Extract Beverage
Intervention Description
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
Intervention Type
Other
Intervention Name(s)
Non-Cranberry Beverage
Intervention Description
Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
Primary Outcome Measure Information:
Title
Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Time Frame
0, 2, 4, 8, 24 h
Title
Superoxide Dismutase (SOD) Activity in Red Blood Cells
Time Frame
0, 2, 4, 8, 24 h
Title
Glutathione Peroxidase (GPx) Activity in Red Blood Cells
Time Frame
0, 2, 4, 8, 24 h
Title
Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)
Time Frame
0, 2, 4, 8, 24 h
Title
C-Reactive Protein (CRP) Concentrations in Plamsa
Time Frame
0, 2, 4, 8, 24 h
Title
Nitric Oxide (NO) Concentrations in Plamsa
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-1alpha (IL-1a) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-1beta (IL-1b) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-2 (IL-2) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-4 (IL-4) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-6 (IL-6) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-8 (IL-8) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interleukin-10 (IL-10) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Interferon-gamma (IFN-y) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
Time Frame
0, 2, 4, 8, 24 h
Title
Urinary Anti-bacteria Adhesion Activity
Time Frame
0, 3, 6, 9, 12, 24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boon P Chew, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
WSU Bioactives Research Lab
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States

12. IPD Sharing Statement

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

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