Cranberry Consumption Improves γδ T Cell Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01713829
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : January 14, 2014
The Cranberry Institute
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Other: Cranberry Beverage Other: Placebo Beverage Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cranberry Consumption Improves γδ T Cell Function
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : August 2013

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01713829

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
Principal Investigator: Susan S Percival, PhD University of Florida

Responsible Party: University of Florida Identifier: NCT01713829     History of Changes
Other Study ID Numbers: CB-472-2012
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

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