Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT02506920
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2015-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-04-06', 'releaseDate': '2017-02-22'}, {'resetDate': '2018-03-08', 'releaseDate': '2017-08-17'}, {'resetDate': '2019-01-18', 'releaseDate': '2018-08-02'}, {'resetDate': '2022-07-11', 'releaseDate': '2022-03-15'}, {'resetDate': '2024-11-21', 'releaseDate': '2024-09-30'}, {'resetDate': '2025-01-16', 'releaseDate': '2024-12-04'}], 'estimatedResultsFirstSubmitDate': '2017-02-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '1997-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial cholesterol', 'timeFrame': 'Eight hours', 'description': 'Cholesterols measured in milli mol per liter'}, {'measure': 'Postprandial free fatty acids', 'timeFrame': 'Eight hours', 'description': 'Free fatty acids measured in micro equivalents per liter'}], 'secondaryOutcomes': [{'measure': 'Postprandial glucose', 'timeFrame': 'Eight hours', 'description': 'Glucose measured in milli mol per liter'}, {'measure': 'postprandial insulin', 'timeFrame': 'Eight hours', 'description': 'Insulin measured in pico mol per liter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postprandial lipemia', 'glycemic response'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '21270379', 'type': 'BACKGROUND', 'citation': 'Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.'}, {'pmid': '23283501', 'type': 'BACKGROUND', 'citation': "Ryan MF, O'Grada CM, Morris C, Segurado R, Walsh MC, Gibney ER, Brennan L, Roche HM, Gibney MJ. Within-person variation in the postprandial lipemic response of healthy adults. Am J Clin Nutr. 2013 Feb;97(2):261-7. doi: 10.3945/ajcn.112.047936. Epub 2013 Jan 2."}, {'pmid': '18347687', 'type': 'BACKGROUND', 'citation': 'Knuth ND, Remias DB, Horowitz JF. Adding carbohydrate to a high-fat meal blunts postprandial lipemia in women and reduces meal-derived fatty acids in systemic circulation. Appl Physiol Nutr Metab. 2008 Apr;33(2):315-25. doi: 10.1139/H07-190.'}, {'pmid': '16226013', 'type': 'BACKGROUND', 'citation': 'Tentor J, Harada LM, Nakamura RT, Gidlund M, Castilho LN, Cotta de Faria E. Sex-dependent variables in the modulation of postalimentary lipemia. Nutrition. 2006 Jan;22(1):9-15. doi: 10.1016/j.nut.2005.05.004. Epub 2005 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects.', 'detailedDescription': "With six different types of butter added in random order to potatoes the investigators studied postprandial lipemia (PPL), lipoprotein, glucose, and insulin increments for eight hours in 14 young, lean, healthy students, seven of each gender.\n\nThe six, isocaloric meals contained 55.1 g carbohydrate, 5.8 g protein, 82.3 g fat, and 4177 kJ. The potatoes, without skin, were boiled in 20 minutes in excess of water with 5 g of salt added, were blended in 4 minutes and served hot. The meals were ingested over 10 minutes, with 250 ml tap water. The following 8 hours the participants stayed at the clinic to watch television, read or take a short walk of 10 minutes.\n\nBlood samples were drawn at -15, 0, 30, 60, 90,120,180,240,300,360, 420 and 480 minutes after the meals and processed after each drawing. After blood collection, plasma was immediately separated by centrifugation at 3000 rpm for 10 minutes at 4°C.\n\nThe area under the curve (AUC) were determined for TG, HDL, LDL, total cholesterol, FFA, insulin, and glucose concentrations by the trapezoid method. Multiple regression was performed to adjust for age, gender, meals, and BMI to the variance of postprandial responses. The difference between meals were tested with ANOVA. If p\\<0.05 in ANOVA, post-hoc-testing with Student-Newman-Keul's test was performed to identify, which meal was significantly different from the other, and to minimize the risk of error by multiple testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accept healthy volunteers\n\nExclusion Criteria:\n\n* hypercholesterolemia,\n* hypertension,\n* abuse of drugs or alcohol,\n* known kidney, liver, heart and metabolic disease\n* hormonal therapies including oral contraceptives'}, 'identificationModule': {'nctId': 'NCT02506920', 'briefTitle': 'Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects', 'orgStudyIdInfo': {'id': 'Gender and PPL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pack butter', 'description': 'Oral fat tolerance test contains: Cream, lactic acid culture, salt. Fat contents in grams: Saturated fat (SFA) 52, monounsaturated fat (MUFA) 19.1, polyunsaturated fat (PUFA) 1.6', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kjaergaarden blend butter', 'description': 'Oral fat tolerance test contains:Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 37.4, MUFA 27.3, PUFA 1.8', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blend butter', 'description': 'Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 23.7, MUFA 23.2, PUFA 7.8', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil enriched butter', 'description': 'Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, fish oil, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 0.7', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olive oil enriched butter', 'description': 'Oral fat tolerance test contains: Butter rapeseed oil, olive oil, lactic acid culture, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 5.7', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low saturated fat butter', 'description': 'Oral fat tolerance test contains: Butter, lactic acid culture, salt. Fat contents in grams: SFA14.9, MUFA16, PUFA 5.6', 'interventionNames': ['Dietary Supplement: Six different types of fat in a meal in random order']}], 'interventions': [{'name': 'Six different types of fat in a meal in random order', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral fat tolerance test', 'armGroupLabels': ['Blend butter', 'Fish oil enriched butter', 'Kjaergaarden blend butter', 'Low saturated fat butter', 'Olive oil enriched butter', 'Pack butter']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ole W Rasmussen, DrMedScie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Kolding Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kolding Sygehus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Finn Friis Lauszus', 'investigatorAffiliation': 'Herning Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-02-22', 'type': 'RELEASE'}, {'date': '2017-04-06', 'type': 'RESET'}, {'date': '2017-08-17', 'type': 'RELEASE'}, {'date': '2018-03-08', 'type': 'RESET'}, {'date': '2018-08-02', 'type': 'RELEASE'}, {'date': '2019-01-18', 'type': 'RESET'}, {'date': '2022-03-15', 'type': 'RELEASE'}, {'date': '2022-07-11', 'type': 'RESET'}, {'date': '2024-09-30', 'type': 'RELEASE'}, {'date': '2024-11-21', 'type': 'RESET'}, {'date': '2024-12-04', 'type': 'RELEASE'}, {'date': '2025-01-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Finn Lauszus, Senior Consultant, Herning Hospital'}}}}