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Cranberry Enhances Human Immune Function and Reduces Illness

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01398150
First received: July 18, 2011
Last updated: September 16, 2011
Last verified: February 2010
History of Changes
  Purpose

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 Intervention
Healthy Humans
 Dietary Supplement: Beverage made to look like the cranberry beverage
Dietary Supplement: Beverage made from cranberry compounds

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cranberry Enhances Human Immune Function and Reduces Illness

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Physiological modifications to immune cell function [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    Proliferation of γδ-T cells when cultured ex vivo in autologous serum


Secondary Outcome Measures:
  • Cold and flu symptoms [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    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.

  • Anti-inflammatory outcome [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells


Enrollment: 54
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398150

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01398150     History of Changes
Other Study ID Numbers: CB-79545
Study First Received: July 18, 2011
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
gamma delta T cell
proliferation
cytokine secretion
immune function
antioxidant status

ClinicalTrials.gov processed this record on May 23, 2013