- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780922
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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.
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