Cranberry Enhances Human Immune Function and Reduces Illness

• ClinicalTrials.gov Identifier: NCT01398150
• Recruitment Status: Completed
• First Posted: July 20, 2011
• Last Update Posted: September 20, 2011
• Sponsor: University of Florida
• Collaborator: Ocean Spray, Inc.
• Information provided by (Responsible Party): University of Florida

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy Humans	Dietary Supplement: Beverage made to look like the cranberry beverage; Dietary Supplement: Beverage made from cranberry compounds	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cranberry Enhances Human Immune Function and Reduces Illness
• Study Start Date: March 2009
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Physiological modifications to immune cell function [ Time Frame: 70 days ]
   Proliferation of γδ-T cells when cultured ex vivo in autologous serum

Secondary Outcome Measures :

1. Cold and flu symptoms [ Time Frame: 70 days ]
   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.
2. Anti-inflammatory outcome [ Time Frame: 70 days ]
   Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Florida

449 Food Science and Human Nutrition Department

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Ocean Spray, Inc.

Investigators

• Principal Investigator: Susan S Percival, PhD; University of Florida

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01398150
• Other Study ID Numbers: CB-79545
• First Posted: July 20, 2011
• Last Update Posted: September 20, 2011
• Last Verified: February 2010

Keywords provided by University of Florida:

gamma delta T cell; proliferation; cytokine secretion; immune function; antioxidant status