Text Size

Cranberry Consumption Improves γδ T Cell Function

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Cranberry Institute
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01713829
First received: September 18, 2012
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Cranberry Beverage
Other: Placebo Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cranberry Consumption Improves γδ T Cell Function

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in Immune Cell Function [ Time Frame: Measured at baseline and 6 weeks ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • Cold and Flu Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713829

Locations
United States, Florida
449 Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
The Cranberry Institute
Investigators
Principal Investigator: Susan S Percival, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01713829     History of Changes
Other Study ID Numbers: CB-472-2012
Study First Received: September 18, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
cranberry
gamma delta T cell
improvement in immune cell function in healthy humans
proliferation

ClinicalTrials.gov processed this record on May 19, 2013