Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03499327
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Human Intervention Study to Increase 25-hydroxyvitamin D Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C050055', 'term': 'wheat germ oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The wheat germ oil is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The randomized, single-blind human intervention study will be conducted in parallel design.\n\nHalf of the participants (n = 17) will consume wheat germ oil UV-treated (intervention) and half of the participants (n = 17) will consume wheat germ oil untreated (placebo). The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).\n\nThe third group (n = 16) do not receive any study products (control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D status', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'plasma levels of 25OHD2, 25OHD3 (nmol/l)'}], 'secondaryOutcomes': [{'measure': 'Blood lipids', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)'}, {'measure': 'Blood glucose', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'fasting blood glucose (mmol/l)'}, {'measure': 'Insulin', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'insulin (units/ml)'}, {'measure': 'soluble Klotho (sKlotho)', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'sKlotho is a component of the FGF23 system and is associated with longevity'}, {'measure': 'Fibroblast growth factor 23 (FGF23)', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure'}, {'measure': 'Fatty acid distribution (erythrocytes)', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': 'fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)'}, {'measure': 'Vitamin D forms 1', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': '1,25(OH)2D2 (nmol/l)'}, {'measure': 'Vitamin D forms 2', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': '1,25(OH)2D3 (nmol/l)'}, {'measure': 'Vitamin D forms 3', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': '24,25(OH)2D (nmol/l)'}, {'measure': 'Vitamin D forms 4', 'timeFrame': 'change from baseline after 3 and 6 weeks', 'description': '20(OH)D (nmol/l)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D', 'ergosterol', '7-dehydro-cholesterol', 'wheat germ oil'], 'conditions': ['Vitamin D3 Deficiency']}, 'referencesModule': {'references': [{'pmid': '35220442', 'type': 'DERIVED', 'citation': 'Bailer AC, Philipp S, Staudt S, Weidauer T, Kiehntopf M, Lorkowski S, Stangl GI, Dawczynski C. UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D2 without improving overall vitamin D status: a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2571-2583. doi: 10.1007/s00394-022-02827-w. Epub 2022 Feb 27.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s00394-022-02827-w', 'label': 'Study results'}]}, 'descriptionModule': {'briefSummary': 'The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.', 'detailedDescription': 'The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans.\n\nWheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study.\n\nHalf of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up).\n\nOn the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels.\n\nThe comparison is made against the intake of traditional (untreated) wheat germ oil (control).\n\nThe study fits with the strategy of the Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany (www.nutriCARD.de) and the study collaborators are active members of the nutriCARD cluster.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects\n* plasma 25(OH) vitamin D \\< 50 nmol/l\n* nutritional habits: western diet\n\nExclusion Criteria:\n\n* intake of lipid-lowering medications\n* gastrointestinal diseases, diabetes mellitus type I and II\n* intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study\n* relevant food allergies / intolerances\n* visit to the solarium (within 4 weeks before beginning of the study and during the study)\n* stay in the mountains / skiing (within 4 weeks before beginning of studies and during the study)'}, 'identificationModule': {'nctId': 'NCT03499327', 'acronym': 'WeKo', 'briefTitle': 'Human Intervention Study to Increase 25-hydroxyvitamin D Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)', 'orgStudyIdInfo': {'id': 'H5_18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wheat germ oil (UV treated)', 'description': 'Wheat germ oil (UV treated)', 'interventionNames': ['Dietary Supplement: Wheat germ oil (UV treated)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Wheat germ oil (untreated)', 'description': 'Wheat germ oil (untreated)', 'interventionNames': ['Dietary Supplement: Wheat germ oil (untreated)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no study products'}], 'interventions': [{'name': 'Wheat germ oil (UV treated)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study (wheat germ oil (UV treated).\n\nThe wheat germ oil (UV treated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.\n\nThe daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).\n\nRecommendation for intake: pure before a main meal.', 'armGroupLabels': ['Wheat germ oil (UV treated)']}, {'name': 'Wheat germ oil (untreated)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'commercial available wheat germ oil The wheat germ oil (untreated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.\n\nThe daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).\n\nRecommendation for intake: pure before a main meal.', 'armGroupLabels': ['Wheat germ oil (untreated)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich-Schiller-University', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Junior Research Group Nutritional Concepts', 'investigatorFullName': 'Christine Dawczynski,PhD', 'investigatorAffiliation': 'University of Jena'}}}}