Cranberry Consumption Improves γδ T Cell Function

NCT ID: NCT01713829

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Cranberry Beverage

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

Group Type: EXPERIMENTAL

Cranberry Beverage

Intervention Type: OTHER

8 oz cranberry beverage consumed daily for 12 weeks

Placebo Beverage

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

Group Type: PLACEBO_COMPARATOR

Placebo Beverage

Intervention Type: OTHER

8 oz placebo beverage consumed daily for 12 weeks

Interventions

Cranberry Beverage

8 oz cranberry beverage consumed daily for 12 weeks

Intervention Type: OTHER

Placebo Beverage

8 oz placebo beverage consumed daily for 12 weeks

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cranberry Institute

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan S Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

449 Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

CB-472-2012

Identifier Type: -

Identifier Source: org_study_id