NCT01780922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

January 29, 2013

Results QC Date

April 22, 2014

Last Update Submit

June 4, 2014

Conditions

Keywords

InflammationOxidative StressVaccinium macrocarpon

Outcome Measures

Primary Outcomes (16)

  • Reduced Glutathione (GSH) Concentrations in Red Blood Cells

    0, 2, 4, 8, 24 h

  • Superoxide Dismutase (SOD) Activity in Red Blood Cells

    0, 2, 4, 8, 24 h

  • Glutathione Peroxidase (GPx) Activity in Red Blood Cells

    0, 2, 4, 8, 24 h

  • Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)

    0, 2, 4, 8, 24 h

  • C-Reactive Protein (CRP) Concentrations in Plamsa

    0, 2, 4, 8, 24 h

  • Nitric Oxide (NO) Concentrations in Plamsa

    0, 2, 4, 8, 24 h

  • Interleukin-1alpha (IL-1a) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-1beta (IL-1b) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-2 (IL-2) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-4 (IL-4) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-6 (IL-6) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-8 (IL-8) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interleukin-10 (IL-10) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Interferon-gamma (IFN-y) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma

    0, 2, 4, 8, 24 h

  • Urinary Anti-bacteria Adhesion Activity

    0, 3, 6, 9, 12, 24 h

Study Arms (3)

Low Calorie Cranberry Juice Cocktail

ACTIVE COMPARATOR

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

Other: Low Calorie Cranberry Juice Cocktail

Cranberry Extract Beverage

ACTIVE COMPARATOR

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

Other: Cranberry Extract Beverage

Non-Cranberry Beverage

PLACEBO COMPARATOR

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

Other: Non-Cranberry Beverage

Interventions

Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes

Low Calorie Cranberry Juice Cocktail

Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes

Cranberry Extract Beverage

Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes

Non-Cranberry Beverage

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men \& women; aged 18-35 years
  • BMI: 19-25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WSU Bioactives Research Lab

Pullman, Washington, 99164, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boon P. Chew
Organization
Washington State Unviversity

Study Officials

  • Boon P Chew, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

July 8, 2014

Results First Posted

July 8, 2014

Record last verified: 2014-06

Locations