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Clinical Trials/NCT01713829
NCT01713829CompletedNot Applicable

Cranberry Consumption Improves γδ T Cell Function

University of Florida1 site in 1 country52 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
Change in Immune Cell Function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 35 Years (Adult)
Sex
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

Arms & Interventions

Cranberry Beverage

Experimental

Cranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks

Intervention: Cranberry Beverage (Other)

Placebo Beverage

Placebo Comparator

The placebo beverage looks like the active arm and is given in the same way but contains no active ingredient.

Intervention: Placebo Beverage (Other)

Outcomes

Primary Outcomes

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

  • Cold and Flu Symptoms(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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