Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-30 @ 11:27 PM
Study NCT ID:
NCT01727895
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047071', 'term': 'beta-Glucans'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jenneke.Leentjens@radboudumc.nl', 'phone': '0031-243668420', 'title': 'Drs. Jenneke Leentjens', 'organization': 'Radboud UMC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Beta-glucan', 'description': 'Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.\n\nBeta-glucan (Glucan #300®)', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No intervention', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flare of acne, one week after discontinuation of Beta-glucan intake', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': 'Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.\n\nBeta-glucan (Glucan #300®)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '691', 'groupId': 'OG000', 'lowerLimit': '276', 'upperLimit': '2649'}, {'value': '749', 'groupId': 'OG001', 'lowerLimit': '287', 'upperLimit': '1160'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 21 days', 'description': 'The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)', 'timeFrame': 'days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA', 'timeFrame': 'Days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.', 'timeFrame': 'Days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)', 'timeFrame': 'Days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).', 'timeFrame': 'Days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'the Composition of Faecal Microbiota', 'timeFrame': 'Days 0, 6, 21', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Beta-glucan', 'description': 'Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.\n\nBeta-glucan (Glucan #300®)'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment took place from April until May 2013 in the Radboud University Medical Centre Nijmegen.', 'preAssignmentDetails': 'Exclusion of subjects was based on pre-defined exclusion criteria or the unability of subjects to comply with the study time schedule.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Beta-glucan', 'description': 'Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.\n\nBeta-glucan (Glucan #300®)'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '22'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '24'}, {'value': '20', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'TNF-α Secretion by ex Vivo LPS-Stimulated Peripheral Blood mononuclear cells', 'classes': [{'categories': [{'measurements': [{'value': '691', 'groupId': 'BG000', 'lowerLimit': '276', 'upperLimit': '2649'}, {'value': '749', 'groupId': 'BG001', 'lowerLimit': '287', 'upperLimit': '1160'}, {'value': '720', 'groupId': 'BG002', 'lowerLimit': '282', 'upperLimit': '1905'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-01', 'studyFirstSubmitDate': '2012-11-12', 'resultsFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2012-11-15', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-01', 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)', 'timeFrame': 'up to 21 days', 'description': 'The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response'}], 'secondaryOutcomes': [{'measure': '• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)', 'timeFrame': 'days 0, 6, 21'}, {'measure': '• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA', 'timeFrame': 'Days 0, 6, 21'}, {'measure': '• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.', 'timeFrame': 'Days 0, 6, 21'}, {'measure': '• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)', 'timeFrame': 'Days 0, 6, 21'}, {'measure': '• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).', 'timeFrame': 'Days 0, 6, 21'}, {'measure': 'the Composition of Faecal Microbiota', 'timeFrame': 'Days 0, 6, 21'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Betaglucan, immune modulation, immunoparalysis, immune suppression'], 'conditions': ['Immunologic Deficiency Syndromes']}, 'referencesModule': {'references': [{'pmid': '25268806', 'type': 'DERIVED', 'citation': 'Leentjens J, Quintin J, Gerretsen J, Kox M, Pickkers P, Netea MG. The effects of orally administered Beta-glucan on innate immune responses in humans, a randomized open-label intervention pilot-study. PLoS One. 2014 Sep 30;9(9):e108794. doi: 10.1371/journal.pone.0108794. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.', 'detailedDescription': 'The immunostimulatory properties of mushrooms have been recognized for centuries, and "medicinal" mushrooms are still widely used in alternative medicine all over the world. Although a number of fungal components have been implicated in these properties, Beta-glucans have attracted the most attention. However, although Beta-glucans are widely used as a health food supplement, their immunomodulatory effects after administration in humans have not yet been determined.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age ≥18\n* Healthy males\n\nExclusion Criteria:\n\n* Subjects with a history of allergy or intolerance to Beta-glucan\n* Use of any medication\n* Participation in a drug trial or donation of blood 3 months prior to Beta-glucan administration\n* Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive agents (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).'}, 'identificationModule': {'nctId': 'NCT01727895', 'acronym': 'BG', 'briefTitle': 'Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study', 'orgStudyIdInfo': {'id': 'Betaglucan_immunity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta-glucan', 'description': 'Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.', 'interventionNames': ['Dietary Supplement: Beta-glucan (Glucan #300®)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Beta-glucan (Glucan #300®)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beta-glucan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Mihai Netea, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Nijmegen Medical Centre, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}