Cranberry Enhances Human Immune Function and Reduces Illness

The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.

Study Overview

• Status: Completed
• Conditions: Healthy Humans
• Intervention / Treatment: Dietary supplement: Beverage made to look like the cranberry beverage; Dietary supplement: Beverage made from cranberry compounds

Detailed Description

The study will be conducted as a randomized, double blind, placebo-controlled parallel trial. Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the Placebo group and each will be instructed to consume the test beverages twice a day for 70 days. The beverage is not commercially prepared juice, but is a beverage prepared with an extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24 hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B and NK cell numbers and then cultured in autologous serum for 10 days to determine how well they proliferate. The supernatant of 24 hour cultures will be used for cytokine determination. If cells have been primed by the beverage made with cranberry compounds, the investigators expect the cells to proliferate to a greater extent and have modified cytokine production compared to placebo. If the beverage made with cranberry compounds enhances the proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the cranberry beverage. Incidence of illness is not expected to change, only the severity of the illness.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • 449 Food Science and Human Nutrition Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Health male or non-pregnant female
• Between the ages of 21 and 50
• BMI between 18 and 35

Exclusion Criteria:

• High blood pressure define as 140/90
• Ongoing or chronic illness or infection
• On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
• Taking plant-based dietary supplements, antioxidant supplements, or probiotics
• Vegetarian or strict vegan
• Consume more than 1 cup of tea (iced or hot) per day
• Consumes more than 2 glasses of alcoholic beverages per day
• Consume more than 7 fruits and vegetables per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sweetened Beverage; looks like and is given in the same way as the experimental treatment but contains no active ingredient	Dietary supplement: Beverage made to look like the cranberry beverage; one 15 ounce bottle of beverage consumed daily
Experimental: Cranberry Beverage; 15 ounce bottle of cranberry beverage consumed daily for 70 days	Dietary supplement: Beverage made from cranberry compounds; one 15 ounce bottle consumed daily for 70 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological modifications to immune cell function	Proliferation of γδ-T cells when cultured ex vivo in autologous serum	70 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold and flu symptoms	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, medications prescribed or purchased OTC.	70 days
Anti-inflammatory outcome	Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells	70 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Ocean Spray, Inc.

Publications and helpful links

General Publications

• Nantz MP, Rowe CA, Muller C, Creasy R, Colee J, Khoo C, Percival SS. Consumption of cranberry polyphenols enhances human gammadelta-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study. Nutr J. 2013 Dec 13;12:161. doi: 10.1186/1475-2891-12-161.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: immune function; proliferation; antioxidant status; gamma delta T cell; cytokine secretion
• Other Study ID Numbers: CB-79545