Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 12:34 PM
Study NCT ID:
NCT05074303
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2021-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Beta-glucan and Immune Response to Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D047071', 'term': 'beta-Glucans'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wdahl@ufl.edu', 'phone': '3522943707', 'title': 'Dr. Wendy Dahl', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '42 days', 'eventGroups': [{'id': 'EG000', 'title': 'Beta-glucan', 'description': "500 mg/day beta-glucan\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nBeta-glucan: 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '500 mg/day cellulose\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nPlacebo: 2 - 250 mg capsules/day of cellulose', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': "500 mg/day beta-glucan\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nBeta-glucan: 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast"}, {'id': 'OG001', 'title': 'Placebo', 'description': '500 mg/day cellulose\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nPlacebo: 2 - 250 mg capsules/day of cellulose'}], 'classes': [{'title': 'Baseline (Mean of Day -14 and Day 0)', 'categories': [{'measurements': [{'value': '127', 'spread': '105', 'groupId': 'OG000'}, {'value': '143', 'spread': '172', 'groupId': 'OG001'}]}]}, {'title': 'Intervention (Day 28)', 'categories': [{'measurements': [{'value': '241', 'spread': '272', 'groupId': 'OG000'}, {'value': '160', 'spread': '165', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days (mean of Day -14 and 0 compared to Day 28)', 'description': 'Change in influenza-specific antibody influenza A titer to the influenza vaccine after beta-glucan supplementation. Titer from 0 to 1024; higher titer indicates stronger immune response.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 40 participants were randomized to the placebo group and 38 to the beta-glucan group over two vaccination seasons. However, the antibody titer could only be analyzed in Season 1 (19 to placebo and 24 to beta-glucan) due to an ineffective influenza antigen source, which explains the discrepancy.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Cytokine Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': '500 mg/day beta-glucan'}, {'id': 'OG001', 'title': 'Placebo', 'description': '500 mg/day cellulose'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days (Day 0, Day 1, and Day 28)', 'description': 'Change in IFN-γ', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'IFN-γ was analyzed in all participants in season 1 and season 2.', 'anticipatedPostingDate': '2025-06'}, {'type': 'SECONDARY', 'title': 'Incidence of Influenza and Covid-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': '500 mg/day beta-glucan'}, {'id': 'OG001', 'title': 'Placebo', 'description': '500 mg/day cellulose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Self-reported incidence of influenza and Covid-19', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on all participants in Season 1 and Season 2.'}, {'type': 'SECONDARY', 'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': '500 mg/day beta-glucan'}, {'id': 'OG001', 'title': 'Placebo', 'description': '500 mg/day cellulose'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of subjects with self-reported fever', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on all participants in season 1 and season 2.'}, {'type': 'SECONDARY', 'title': 'Cold and Flu Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beta-glucan', 'description': '500 mg/day beta-glucan'}, {'id': 'OG001', 'title': 'Placebo', 'description': '500 mg/day cellulose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cold and flu symptoms were monitored in all participants in Seasons 1 and 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Beta-glucan', 'description': "500 mg/day beta-glucan\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nBeta-glucan: 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast"}, {'id': 'FG001', 'title': 'Placebo', 'description': '500 mg/day cellulose\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nPlacebo: 2 - 250 mg capsules/day of cellulose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Beta-glucan', 'description': "500 mg/day beta-glucan\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nBeta-glucan: 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast"}, {'id': 'BG001', 'title': 'Placebo', 'description': '500 mg/day cellulose\n\nInfluenza Vaccine: All subjects will receive the influenza vaccine.\n\nPlacebo: 2 - 250 mg capsules/day of cellulose'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '9', 'groupId': 'BG000'}, {'value': '71', 'spread': '11', 'groupId': 'BG001'}, {'value': '71', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-21', 'size': 260874, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-21T12:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2021-09-29', 'resultsFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-21', 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Titer', 'timeFrame': '42 days (mean of Day -14 and 0 compared to Day 28)', 'description': 'Change in influenza-specific antibody influenza A titer to the influenza vaccine after beta-glucan supplementation. Titer from 0 to 1024; higher titer indicates stronger immune response.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Cytokine Profile', 'timeFrame': '28 days (Day 0, Day 1, and Day 28)', 'description': 'Change in IFN-γ'}, {'measure': 'Incidence of Influenza and Covid-19', 'timeFrame': '28 days', 'description': 'Self-reported incidence of influenza and Covid-19'}, {'measure': 'Fever', 'timeFrame': '28 days', 'description': 'Number of subjects with self-reported fever'}, {'measure': 'Cold and Flu Symptoms', 'timeFrame': '28 days', 'description': 'Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['beta-glucan; influenza; immunity; antibodies'], 'conditions': ['Healthy Aging']}, 'referencesModule': {'references': [{'pmid': '40746014', 'type': 'DERIVED', 'citation': 'Moreno ML, Nieves CJ, Hebert K, Vivas CA, Rivero-Mendoza D, Colee J, Tompkins TA, Dahl WJ. Yeast Beta-Glucan Enhances Antibody Response Following Influenza Vaccination - A Double-Blind, Randomized, Placebo-Controlled Pilot Trial. J Diet Suppl. 2025;22(5):795-810. doi: 10.1080/19390211.2025.2539876. Epub 2025 Jul 31.'}]}, 'descriptionModule': {'briefSummary': "This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker's yeast, on immune response to the influenza vaccine.", 'detailedDescription': 'Beta-glucans have been shown to enhance the innate and adaptive immune responses in cell cultures, animal models, and humans, thus adults over the age of 50 years receiving the influenza vaccination may benefit in terms of their immune response from supplementation with beta-glucans. This is a 6-week randomized, double-blind, placebo-controlled, 2-arm parallel study designed to evaluate the adjuvant effect of beta-glucan dietary supplementation during influenza vaccination. Participants will consume either the beta-glucan or placebo capsules for 42 days. Participants will complete an online Qualtrics daily questionnaire of compliance, fatigue, and cold and flu symptoms throughout the 42-day study. Influenza vaccine will be administered on or about day 14. The Gastrointestinal Symptom Rating Scale (GSRS) and the Mood and Feelings Questionnaire (MFQ) will be completed at baseline, 2 weeks and 6 weeks. Blood draws for antibody and cytokine response will be completed at baseline, and on or about days 14 and 15, and on day 42.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult volunteers ≥ 50 years of age.\n2. Planning to be vaccinated for influenza\n3. Have been immunized for COVID-19\n4. Willing and able to provide written informed consent in English.\n5. Willing and able to comply with all the study-related procedures, including attending to study visits for blood draw, taking the influenza vaccine, intake of the study supplement, and completing study questionnaires.\n\nExclusion Criteria:\n\n1. Demonstrate an inability to comply with the study-related procedures.\n2. Have a history of a severe reaction or hypersensitivity following vaccination with influenza vaccine, vaccination with any other vaccine containing the same substances, or intake of the study product.\n3. Have an immune system alteration because of an underlying illness (e.g., autoimmune disease) or immune-suppressing treatment (e.g., steroids (last 30 days); cytotoxic drugs, medical surgery, or radiation therapy during the 6 months, previous to enrollment).\n4. Be concurrently participating in a clinical trial that, in the judgement of the investigator, would interfere with the evaluation of the study outcomes.'}, 'identificationModule': {'nctId': 'NCT05074303', 'acronym': 'M-Unity', 'briefTitle': 'Beta-glucan and Immune Response to Influenza Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)', 'orgStudyIdInfo': {'id': 'IRB202101959'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta-glucan', 'description': '500 mg/day beta-glucan', 'interventionNames': ['Biological: Influenza Vaccine', 'Dietary Supplement: Beta-glucan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '500 mg/day cellulose', 'interventionNames': ['Biological: Influenza Vaccine', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'All subjects will receive the influenza vaccine.', 'armGroupLabels': ['Beta-glucan', 'Placebo']}, {'name': 'Beta-glucan', 'type': 'DIETARY_SUPPLEMENT', 'description': "2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast", 'armGroupLabels': ['Beta-glucan']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 - 250 mg capsules/day of cellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Food Science and Human Nutrition Department, University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danstar Ferment AG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}