Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-04-17 @ 11:52 AM
Study NCT ID:
NCT01398150
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cranberry Enhances Human Immune Function and Reduces Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological modifications to immune cell function', 'timeFrame': '70 days', 'description': 'Proliferation of γδ-T cells when cultured ex vivo in autologous serum'}], 'secondaryOutcomes': [{'measure': 'Cold and flu symptoms', 'timeFrame': '70 days', 'description': '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.'}, {'measure': 'Anti-inflammatory outcome', 'timeFrame': '70 days', 'description': 'Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gamma delta T cell', 'proliferation', 'cytokine secretion', 'immune function', 'antioxidant status'], 'conditions': ['Healthy Humans']}, 'referencesModule': {'references': [{'pmid': '24330619', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health male or non-pregnant female\n* Between the ages of 21 and 50\n* BMI between 18 and 35\n\nExclusion Criteria:\n\n* High blood pressure define as 140/90\n* Ongoing or chronic illness or infection\n* On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS\n* Taking plant-based dietary supplements, antioxidant supplements, or probiotics\n* Vegetarian or strict vegan\n* Consume more than 1 cup of tea (iced or hot) per day\n* Consumes more than 2 glasses of alcoholic beverages per day\n* Consume more than 7 fruits and vegetables per day'}, 'identificationModule': {'nctId': 'NCT01398150', 'briefTitle': 'Cranberry Enhances Human Immune Function and Reduces Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Cranberry Enhances Human Immune Function and Reduces Illness', 'orgStudyIdInfo': {'id': 'CB-79545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sweetened Beverage', 'description': 'looks like and is given in the same way as the experimental treatment but contains no active ingredient', 'interventionNames': ['Dietary Supplement: Beverage made to look like the cranberry beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Cranberry Beverage', 'description': '15 ounce bottle of cranberry beverage consumed daily for 70 days', 'interventionNames': ['Dietary Supplement: Beverage made from cranberry compounds']}], 'interventions': [{'name': 'Beverage made to look like the cranberry beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one 15 ounce bottle of beverage consumed daily', 'armGroupLabels': ['Sweetened Beverage']}, {'name': 'Beverage made from cranberry compounds', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one 15 ounce bottle consumed daily for 70 days', 'armGroupLabels': ['Cranberry Beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': '449 Food Science and Human Nutrition Department', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Susan S Percival, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocean Spray, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}