Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-04 @ 5:04 PM
Study NCT ID:
NCT03010904
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal symptoms (self reported)', 'timeFrame': 'day 0 - day 5', 'description': 'Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.'}], 'secondaryOutcomes': [{'measure': 'Plasma triacylglycerols', 'timeFrame': '20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min'}, {'measure': 'Plasma glucose', 'timeFrame': '20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min'}, {'measure': 'Plasma insulin', 'timeFrame': '20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unidentified Gastrointestinal Discomfort Following Dairy Consumption']}, 'descriptionModule': {'briefSummary': "This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported)\n* age 18-65\n* BMI 18,5 - 30\n* hemoglobin under normal range\n* fasting plasma alanine aminotransferase ALAT \\< 60 U/l (normal liver function)\n* fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)\n* fasting plasma creatinine \\< 118 umol/l (normal kidney function)\n\nExclusion Criteria:\n\n* pace maker\n* Crohn's disease or other disease of the intestinal tract\n* intestinal operation within the last 3 months\n* difficult dysphagia\n* smoking\n* constipation\n* lactose intolerance\n* coeliac disease"}, 'identificationModule': {'nctId': 'NCT03010904', 'briefTitle': "The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults", 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': "The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults", 'orgStudyIdInfo': {'id': 'MILK2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pasteurized milk', 'description': 'milk that has undergone pasteurization treatment', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'homogenized pasteurized milk', 'description': 'Milk that has undergone homogenization and pasteurization treatment', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'UHT milk', 'description': 'Milk that has undergone homogenization and ultra high temperature treatment', 'interventionNames': ['Other: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'OTHER', 'armGroupLabels': ['UHT milk', 'homogenized pasteurized milk', 'pasteurized milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20014', 'city': 'Turku', 'country': 'Finland', 'facility': 'Department of Biochemistry, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '20500', 'city': 'Turku', 'country': 'Finland', 'facility': 'Food Chemistry, Department of Biochemistry, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Kaisa M Linderborg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biochemistry, University of Turku'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kaisa Linderborg', 'investigatorAffiliation': 'University of Turku'}}}}