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Clinical Trials/NCT01398150
NCT01398150
Completed
Not Applicable

Cranberry Enhances Human Immune Function and Reduces Illness

University of Florida1 site in 1 country54 target enrollmentMarch 2009
ConditionsHealthy Humans

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Humans
Sponsor
University of Florida
Enrollment
54
Locations
1
Primary Endpoint
Physiological modifications to immune cell function
Status
Completed
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
May 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Physiological modifications to immune cell function

Time Frame: 70 days

Proliferation of γδ-T cells when cultured ex vivo in autologous serum

Secondary Outcomes

  • Cold and flu symptoms(70 days)
  • Anti-inflammatory outcome(70 days)

Study Sites (1)

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