Cranberry Enhances Human Immune Function and Reduces Illness

NCT ID: NCT01398150

Last Updated: 2011-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-05-31

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.

Conditions

Healthy Humans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Sweetened Beverage

looks like and is given in the same way as the experimental treatment but contains no active ingredient

Group Type: PLACEBO_COMPARATOR

Beverage made to look like the cranberry beverage

Intervention Type: DIETARY_SUPPLEMENT

one 15 ounce bottle of beverage consumed daily

Cranberry Beverage

15 ounce bottle of cranberry beverage consumed daily for 70 days

Group Type: EXPERIMENTAL

Beverage made from cranberry compounds

Intervention Type: DIETARY_SUPPLEMENT

one 15 ounce bottle consumed daily for 70 days

Interventions

Beverage made to look like the cranberry beverage

one 15 ounce bottle of beverage consumed daily

Intervention Type: DIETARY_SUPPLEMENT

Beverage made from cranberry compounds

one 15 ounce bottle consumed daily for 70 days

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ocean Spray, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan S Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

449 Food Science and Human Nutrition Department

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24330619 (View on PubMed)

Other Identifiers

CB-79545

Identifier Type: -

Identifier Source: org_study_id