Cranberry Consumption Improves γδ T Cell Function

January 10, 2014 updated by: University of Florida
The purpose of this study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. It is hypothesized that cranberry components will interact with immune cells to activate signaling pathways that enhance cell function. Enhanced immune cell function should result in reduced number, duration, and severity of cold and flu symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • 449 Food Science and Human Nutrition Department, University of Florida

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

21 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 21 and 35 years of age and in good health
  • have a BMI between 18.5 and 29.9
  • willing to consume the study beverage for 12 weeks
  • willing to have a small amount of blood drawn two times
  • willing to stop consuming tea and immune-enhancing dietary supplements (e.g. antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and Echinacea) before and during the 12 weeks of the study
  • willing to consume no more than 7 servings of fruits and vegetables a day
  • willing to limit your alcohol consumption to no more than 14 glasses a week
  • willing to limit your yogurt consumption to no more than one 8oz. serving per day

Exclusion Criteria:

  • have food allergies
  • have hypertension
  • taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or immunosuppressive drugs
  • sensitive to aspirin or prone to kidney stones
  • current smoker
  • pregnant, lactating, or on hormone therapy, except for birth control pills

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cranberry Beverage
Cranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks
Other: Cranberry Beverage
8 oz cranberry beverage consumed daily for 12 weeks
PLACEBO_COMPARATOR: Placebo Beverage
The placebo beverage looks like the active arm and is given in the same way but contains no active ingredient.
Other: Placebo Beverage
8 oz placebo beverage consumed daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Immune Cell Function
Time Frame: Measured at baseline and 6 weeks
  • Change in leukocyte phenotype
  • Change in the ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo
  • Change in peripheral blood mononuclear cell cytokine and chemokine production in response to mitogens
Measured at baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold and Flu Symptoms
Time Frame: 12 weeks
Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, prescribed or over-the-counter medications taken.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

The Cranberry Institute

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

October 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CB-472-2012

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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