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Completed

NCT Number: NCT01713829

Cranberry Consumption Improves γδ T Cell Function

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.

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Key information

Conditions

Healthy

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

449 Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry Beverage

Other

8 oz cranberry beverage consumed daily for 12 weeks

Placebo beverage

Other

8 oz placebo beverage consumed daily for 12 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • The Cranberry Institute

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2012
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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