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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780922
• Other study ID #: 11369
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: June 4, 2014
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Low Calorie Cranberry Juice Cocktail
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
• Cranberry Extract Beverage
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
• Non-Cranberry Beverage
Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes

Locations

Country	Name	City	State
United States	WSU Bioactives Research Lab	Pullman	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	Ocean Spray Cranberries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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