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Completed

NCT Number: NCT01398150

Cranberry Enhances Human Immune Function and Reduces Illness

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

449 Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beverage made to look like the cranberry beverage

Dietary Supplement

one 15 ounce bottle of beverage consumed daily

Beverage made from cranberry compounds

Dietary Supplement

one 15 ounce bottle consumed daily for 70 days

Primary outcomes

  1. Physiological modifications to immune cell function

    Time frame: 70 days

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

Secondary outcomes

  1. Cold and flu symptoms

    Time frame: 70 days

    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.

  2. Anti-inflammatory outcome

    Time frame: 70 days

    Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Ocean Spray, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 20, 2011
Registry last updated
Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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