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Cranberry Enhances Human Immune Function and Reduces Illness

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

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.

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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

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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398150

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United States, Florida
449 Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Ocean Spray, Inc.
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Principal Investigator: Susan S Percival, PhD University of Florida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01398150    
Other Study ID Numbers: CB-79545
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: February 2010
Keywords provided by University of Florida:
gamma delta T cell
cytokine secretion
immune function
antioxidant status