Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 2:45 AM
Study NCT ID:
NCT05668832
Status:
UNKNOWN
Last Update Posted:
2022-12-30
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-24', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-24', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating vitamin D photoisomers', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Plasma concentrations of vitamin D photoisomers (such as lumisterol, tachysterol and their hydroxy derivates) after the consumption of the UVB-exposed versus non UVB-exposed button mushrooms'}], 'secondaryOutcomes': [{'measure': 'Parameters of vitamin D metabolism', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Plasma concentrations of vitamin D metabolites (vitamin D2, vitamin D3, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, 24,25-dihydroxyvitamin D2, calcitriol, ergosterol)'}, {'measure': 'Parameters of mineral metabolism', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Plasma calcium, phosphate, parathyroid hormone, fibroblast growth factor-23'}, {'measure': 'Plasma lipids', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Plasma triglycerides, cholesterol'}, {'measure': 'Inflammation markers', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Plasma CRP, Interleukin-6'}, {'measure': 'mRNA and protein expression in peripheral mononuclear blood cells', 'timeFrame': 'at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months', 'description': 'Vitamin D receptor target genes, CYP enzymes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumisterol', 'tachysterol', 'hydroxy-photoisomers', 'vitamin D'], 'conditions': ['Dietary Exposure', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.', 'detailedDescription': 'according to protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Age between 18 and 65 years\n* Body Mass Index in the range of 18.5 to 29.9 kg/m2\n\nExclusion Criteria:\n\n* Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)\n* Taking medication (except oral contraceptives)\n* Pregnancy or breastfeeding\n* Food intolerances or allergies to mushrooms and dairy products\n* Smokers\n* Visits to solariums or previous holidays in southern countries or in the Alps or other high mountains\n* Participation in another study\n* Blood donation during the last 2 months before the start of the study\n* Dieting\n* Severe weight loss or weight loss (≥ 3 kg) within the last month'}, 'identificationModule': {'nctId': 'NCT05668832', 'briefTitle': 'Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms', 'orgStudyIdInfo': {'id': 'UHalle 2022-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral intake of UVB-exposed mushrooms', 'description': 'Daily intake of 500 g of UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)', 'interventionNames': ['Dietary Supplement: UVB-exposed button mushrooms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'oral intake of non-UVB-exposed mushrooms', 'description': 'Daily intake of 500 g of non-UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)', 'interventionNames': ['Dietary Supplement: UVB-exposed button mushrooms']}], 'interventions': [{'name': 'UVB-exposed button mushrooms', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Healthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken.', 'armGroupLabels': ['oral intake of UVB-exposed mushrooms', 'oral intake of non-UVB-exposed mushrooms']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gabriele I Stangl, Prof. Dr.', 'role': 'CONTACT', 'email': 'gabriele.stangl@landw.uni-halle.de', 'phone': '+493455522707'}], 'overallOfficials': [{'name': 'Gabriele I Stangl, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Martin-Luther-Universität Halle-Wittenberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Gabriele Stangl', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}