Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06041867
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agaricus Bisporus and Influenza Vaccination Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine specific antibody titer', 'timeFrame': 'Time Frame: Differences in influenza specific antibody titers at any measured time point ((Day=0 (day before vaccination), weekly in the month after vaccination (week 1, week 2, week 3 and week 4 after vaccination))', 'description': 'The response to the Influenza vaccine will be measured by quantifying the specific antibody titer'}], 'secondaryOutcomes': [{'measure': 'Immune parameters (1)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system'}, {'measure': 'Immune parameters (2)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'hsCRP'}, {'measure': 'Leukocyte count', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Number of leukocytes measured in EDTA plasma'}, {'measure': 'Leukocyte differential count', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Number of subgroups of leukocytes measured in EDTA plasma'}, {'measure': 'Fasted metabolism (1)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Serum non-cholesterol sterols and stanols'}, {'measure': 'Fasted metabolism (2)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Serum lipid and lipoprotein profile'}, {'measure': 'Fasted metabolism (3)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Plasma glucose'}, {'measure': 'Fasted metabolism (4)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Ergothioneine'}, {'measure': 'Fasted metabolism (5)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Glutathione'}, {'measure': 'Fasted metabolism (6)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)', 'description': 'Malondialdehyde'}, {'measure': 'Anthropometry (1)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)', 'description': 'Body weight'}, {'measure': 'Anthropometry (2)', 'timeFrame': 'Day -1 (start study)', 'description': 'Height'}, {'measure': 'Anthropometry (3)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)', 'description': 'Waist circumference'}, {'measure': 'Anthropometry (4)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)', 'description': 'Hip circumference'}, {'measure': 'Anthropometry (5)', 'timeFrame': 'Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)', 'description': 'Waist-to-hip ratio'}, {'measure': 'Diet', 'timeFrame': 'Day - 1 (start study), T=4 weeks after vaccination (end of study)', 'description': 'Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume mushrooms outside the intervention'}, {'measure': 'Quality of life questionnaire', 'timeFrame': 'Day - 1 (start study), T=4 weeks after vaccination (end of study)', 'description': 'Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life'}, {'measure': 'Diary outcomes (1)', 'timeFrame': 'Day - 1 (start study), T=4 weeks after vaccination (end of study)', 'description': 'Adverse events as assessed by the diary'}, {'measure': 'Diary outcomes (2)', 'timeFrame': 'Day - 1 (start study), T=4 weeks after vaccination (end of study)', 'description': 'Medication intake as assessed by the diary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Agaricus bisporus', 'Immune system', 'Influenza vaccination', 'Mushroom'], 'conditions': ['Immune Response']}, 'descriptionModule': {'briefSummary': 'There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming Agaricus bisporus powder prior to receiving the influenza vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '59 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 years or older during influenza season 2023/2024 (in line with RIVM guidelines)\n* BMI between 20 and 35 kg/m2\n* Willing to abstain from mushrooms other than the capsules containing a mushroom powder as provided by us during the study period.\n* Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplements constant\n* Willing to abstain from products / supplements enriched with Vitamin D\n* Willing to abstain from products / supplements enriched with plant sterols or stanols\n* Willing to abstain from products / supplements enriched with (β)glucans or fungi.\n* Willing to abstain from products / supplements that are mentioned to "boost your immune system"\n* Willing to abstain from (products enriched in) pre/pro-biotics\n* Willing to abstain from products/supplements enriched with ergothioneine\n\nExclusion Criteria:\n\n* Already received influenza vaccination in 2023\n* Allergy to mushrooms\n* Known allergic reaction to an active component or other components of the vaccine (e.g. Chicken Eggs)\n* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study\n* Excessive alcohol use (\\>20 consumptions per week)\n* Regular use of soft and/or hard drugs\n* Using medication for diseases known to affect inflammation/immunity (e.g. inhaled corticosteroids and prednisone)'}, 'identificationModule': {'nctId': 'NCT06041867', 'briefTitle': 'Agaricus Bisporus and Influenza Vaccination Response', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine', 'orgStudyIdInfo': {'id': 'METC 23-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Agaricus bisporus group', 'description': 'Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each', 'interventionNames': ['Biological: Influenza vaccine', 'Dietary Supplement: Agaricus bisporus capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder', 'interventionNames': ['Biological: Influenza vaccine', 'Dietary Supplement: Control capsules']}], 'interventions': [{'name': 'Influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine', 'armGroupLabels': ['Agaricus bisporus group', 'Placebo group']}, {'name': 'Agaricus bisporus capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants have to consume 10 capsules per day containing 500 mg Agaricus bisporus powder each, corresponding to a total Agariicus bisporus powder intake of 5 g daily', 'armGroupLabels': ['Agaricus bisporus group']}, {'name': 'Control capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scelta Mycofriends B.V.', 'class': 'UNKNOWN'}, {'name': 'CNC Grondstoffen B.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}