Cranberry Consumption Improves γδ T Cell Function

NCT01713829 | Completed

• 1 other identifier: CB-472-2012
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

cranberry; gamma delta T cell; improvement in immune cell function in healthy humans; proliferation

Outcome Measures

Primary Outcomes (1)

• Change in Immune Cell Function

  * 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 Outcomes (1)

• Cold and Flu Symptoms

  12 weeks

Study Arms (2)

Cranberry Beverage

EXPERIMENTAL

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

Other: Cranberry Beverage

Placebo Beverage

PLACEBO COMPARATOR

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

Other: Placebo Beverage

Interventions

Cranberry Beverage OTHER

8 oz cranberry beverage consumed daily for 12 weeks

Cranberry Beverage

Placebo Beverage OTHER

8 oz placebo beverage consumed daily for 12 weeks

Placebo Beverage

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• The Cranberry Institute: collaborator

Study Sites (1)

449 Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Susan S Percival, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

US (1)