Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Washington State University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Interleukin-2 (IL-2) Concentrations in Plasma
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Low Calorie Cranberry Juice Cocktail
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Intervention: Low Calorie Cranberry Juice Cocktail (Other)
Cranberry Extract Beverage
Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Intervention: Cranberry Extract Beverage (Other)
Non-Cranberry Beverage
Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Intervention: Non-Cranberry Beverage (Other)
Outcomes
Primary Outcomes
Interleukin-2 (IL-2) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-1beta (IL-1b) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interferon-gamma (IFN-y) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Urinary Anti-bacteria Adhesion Activity
Time Frame: 0, 3, 6, 9, 12, 24 h
Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Time Frame: 0, 2, 4, 8, 24 h
Superoxide Dismutase (SOD) Activity in Red Blood Cells
Time Frame: 0, 2, 4, 8, 24 h
Glutathione Peroxidase (GPx) Activity in Red Blood Cells
Time Frame: 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
C-Reactive Protein (CRP) Concentrations in Plamsa
Time Frame: 0, 2, 4, 8, 24 h
Nitric Oxide (NO) Concentrations in Plamsa
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-1alpha (IL-1a) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-4 (IL-4) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-6 (IL-6) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-8 (IL-8) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Interleukin-10 (IL-10) Concentrations in Plasma
Time Frame: 0, 2, 4, 8, 24 h
Secondary Outcomes
No secondary outcomes reported