Cranberry Enhances Human Immune Function and Reduces Illness

Healthy Humans Clinical Trial

Official title:

Cranberry Enhances Human Immune Function and Reduces Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398150
• Other study ID #: CB-79545
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: September 16, 2011
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: February 2010
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Humans

Intervention

Dietary Supplement:
• Beverage made to look like the cranberry beverage
one 15 ounce bottle of beverage consumed daily
• Beverage made from cranberry compounds
one 15 ounce bottle consumed daily for 70 days

Locations

Country	Name	City	State
United States	449 Food Science and Human Nutrition Department	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Ocean Spray, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological modifications to immune cell function	Proliferation of ?d-T cells when cultured ex vivo in autologous serum	70 days	No
Secondary	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	No
Secondary	Anti-inflammatory outcome	Serum antioxidant status, cytokine production and proliferation of aß-T, B and NK cells	70 days	No