Clinical trial NCT01398150: Cranberry Enhances Human Immune Function and Reduces Illness
Official title: Cranberry Enhances Human Immune Function and Reduces Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Humans
Keywords: gamma delta T cell
proliferation
cytokine secretion
immune function
antioxidant status
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Ocean Spray, Inc.
First posted: 2011-07-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Physiological modifications to immune cell function
timeFrame: 70 days
Secondary outcomes:
measure: Cold and flu symptoms
timeFrame: 70 days
measure: Anti-inflammatory outcome
timeFrame: 70 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: 449 Food Science and Human Nutrition Department
state: Florida
Study officials:
affiliation: University of Florida
name: Susan S Percival, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.