Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 5:28 AM
Study NCT ID:
NCT03977558
Status:
UNKNOWN
Last Update Posted:
2019-06-10
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Effect of Canola Oil Consumption in Shift Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist circumference (WC)', 'timeFrame': 'Baseline, 4, 8 and 12 week', 'description': 'Changes in WC within groups and between groups'}, {'measure': 'HDL-cholesterol (HDL-C)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in HDL-C within groups and between groups'}, {'measure': 'LDL-cholesterol (LDL-C)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in LDL-C within groups and between groups'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in TG within groups and between groups'}, {'measure': 'Glucose (GLU)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in GLU within groups and between groups'}, {'measure': 'Blood pressure (BP)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in BP within groups and between groups'}, {'measure': 'Body weight (BW)', 'timeFrame': 'Baseline, 4, 8 and 12 week', 'description': 'Changes in BW within groups and between groups'}, {'measure': 'Fat mass (FM)', 'timeFrame': 'Baseline, 4, 8 and 12 week', 'description': 'Changes in FM within groups and between groups'}], 'secondaryOutcomes': [{'measure': 'Insulin (INS)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in INS within groups and between groups'}, {'measure': 'High-sensitivity C-reactive Protein (hs-CRP)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in hs-CRP within groups and between groups'}, {'measure': 'Cardiotrophin-1 (CT-1)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in CT-1 within groups and between groups'}, {'measure': 'Lipase (LPS)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in LPS within groups and between groups'}, {'measure': 'Cholinesterase (CHE)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in CHE within groups and between groups respectively'}, {'measure': 'Alanine transaminase (ALT)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in ALT within groups and between groups'}, {'measure': 'Aspartate transaminase (AST)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in AST within groups and between groups'}, {'measure': 'Gamma-glutamyltransferase (GGTP)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in GGTP within groups and between groups'}, {'measure': 'Melatonin (MEL)', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in MEL within groups and between groups'}, {'measure': 'Fatty acids (FA) erythrocyte membranes concentration', 'timeFrame': 'Baseline, 12 week', 'description': 'Changes in FA within groups and between groups'}, {'measure': 'Dietary intake', 'timeFrame': 'Baseline, 4, 8, 12 week', 'description': 'Changes in dietary intake within groups and between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shift Work', 'Night Work', 'Rotating Shift Work', 'Metabolic Syndrome', 'Diet Therapy', 'Canola oil', 'Fatty Acids', 'Cardiometabolic parameters'], 'conditions': ['Shift-Work Related Sleep Disturbance', 'Metabolic Syndrome', 'Diet Modification', 'Work-Related Condition']}, 'descriptionModule': {'briefSummary': 'Shift work is associated with a higher risk of the development of cardiometabolic syndrome (CMtS) than in people working only during the day. One of the factors predisposing to the development of the CMtS in shift workers is an inappropriate composition of their diet. It was observed that the shift workers diet is characterized by a higher intake of saturated fatty acids (SFA) and a lower consumption of unsaturated fatty acids. One potential way to reduce the risk of CMtS in this study group seems to be a modification of their everyday diet by excluding the products of animal origin (e.g. butter) with simultaneously including vegetable oils (i.e. canola oil). The aim of the study is to evaluate the effect of replacement in the everyday diet of saturated fats (butter) with unsaturated fats (canola oil-based spread and canola oil added to main meals) in centrally obese shift workers on changes in body weight and body composition parameters as well as on changes in CMtS markers.', 'detailedDescription': 'The study was designed as a randomized clinical trial to investigate the effects of the dietary intervention with moderate in fat content (\\~35% energy as fat) for 12 weeks on the improvement of cardiometabolic risk factors in centrally obese shift workers. Forty centrally obese shift workers (waist circumference ≥94 cm) were randomized (1:1) to the experimental group (n = 20) or the control group (n = 20). Eligibility criteria included: aged between 30-60 years, working rotating shifts for at least 5 years and working night shifts minimum five times a month. Excluded criteria was described in the point "Eligibility". Written informed consent was obtained from all of the participants, and the local ethic committee approved the study. The dietary intervention was mainly based on the simple rearrangement of shift workers\' diets by replacing food items including SFA (e.g. butter) with those being sources of unsaturated fatty acids (UFA), mainly canola oil (given to the diet as spread or this oil was added separately to main meals)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* centrally obese (≥ 94cm) male\n* aged between 30-60 years,\n* working rotating shifts for at least 5 years and working night shifts minimum five times a month,\n\nExclusion Criteria:\n\n* diabetes, familial hypercholesterolemia, thyroid and parathyroid diseases, non-specific intestinal diseases, celiac disease, phenylketonuria,\n* taking medication for lowering blood lipids such as statins,\n* weight loss therapy for 3 months before the intervention,\n* allergies and intolerances\n* consuming high-proof alcoholic beverages (\\>2 portions/week)'}, 'identificationModule': {'nctId': 'NCT03977558', 'briefTitle': 'Health Effect of Canola Oil Consumption in Shift Workers', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Life Sciences'}, 'officialTitle': 'The Effect of Canola Oil Consumption on the Selected Cardiometabolic Parameters in a Group of Shift Workers', 'orgStudyIdInfo': {'id': 'IoHNaD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Isocaloric diet, based on individual energy requirements calculated from indirect calorimetry and physical activity adjustment Participants will be asked to eat daily \\~50g canola oil', 'interventionNames': ['Behavioral: Intervention group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard dietary advice that is used as current best practice in the treatment of lipid disturbances of European Society of Cardiology and European Atherosclerosis Society (ESC/EAS) Guidelines for the management of dyslipidemias)', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': 'Isocaloric diet including \\~50g canola oil', 'armGroupLabels': ['Intervention group']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'ESC/EAS Guidelines for the management of dyslipidemias', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-624', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Agnieszka Kuleta-Koberska, MSc', 'role': 'CONTACT', 'email': 'agnieszka.kuleta@up.poznan.pl', 'phone': '+48618487594'}, {'name': 'Joanna Bajerska, Prof.', 'role': 'CONTACT', 'email': 'joanna.bajerska@up.poznan.pl', 'phone': '+48618466056'}, {'name': 'Agnieszka Kuleta-Koberska, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poznan University of Life Science', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Agnieszka Kuleta-Koberska, MSc', 'role': 'CONTACT', 'email': 'agnieszka.kuleta@up.poznan.pl', 'phone': '+48618467594'}, {'name': 'Joanna Bajerska, Prof.', 'role': 'CONTACT', 'email': 'joanna.bajerska@up.poznan.pl', 'phone': '+48618466056'}], 'overallOfficials': [{'name': 'Agnieszka Kuleta-Koberska, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Life Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Life Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Agnieszka Kuleta-Koberska', 'investigatorAffiliation': 'Poznan University of Life Sciences'}}}}