Clinical trial NCT01780922: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Inflammation
Oxidative Stress
Vaccinium macrocarpon
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Ocean Spray Cranberries, Inc.
First posted: 2013-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Reduced Glutathione (GSH) Concentrations in Red Blood Cells
timeFrame: 0, 2, 4, 8, 24 h
measure: Superoxide Dismutase (SOD) Activity in Red Blood Cells
timeFrame: 0, 2, 4, 8, 24 h
measure: Glutathione Peroxidase (GPx) Activity in Red Blood Cells
timeFrame: 0, 2, 4, 8, 24 h
measure: Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)
timeFrame: 0, 2, 4, 8, 24 h
measure: C-Reactive Protein (CRP) Concentrations in Plamsa
timeFrame: 0, 2, 4, 8, 24 h
measure: Nitric Oxide (NO) Concentrations in Plamsa
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-1alpha (IL-1a) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-1beta (IL-1b) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-2 (IL-2) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-4 (IL-4) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-6 (IL-6) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-8 (IL-8) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interleukin-10 (IL-10) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Interferon-gamma (IFN-y) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
timeFrame: 0, 2, 4, 8, 24 h
measure: Urinary Anti-bacteria Adhesion Activity
timeFrame: 0, 3, 6, 9, 12, 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Pullman
country: United States
facility: WSU Bioactives Research Lab
state: Washington
Study officials:
affiliation: Washington State University
name: Boon P Chew, PhD
role: PRINCIPAL_INVESTIGATOR
References: