Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02729857
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in levels of circulating triglycerides', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}], 'secondaryOutcomes': [{'measure': 'Changes in markers of lipid- and glucose metabolism', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, apolipoprotein (apo) B, apo A1, apo CIII, apo B48, lipoprotein (a), free fatty acids, total fatty acid composition, LDL-receptor-related protein with 11 ligand-binding repeats (LR11), HbA1c, glucose, insulin and troponin.'}, {'measure': 'Changes in circulating levels of inflammatory markers', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP'}, {'measure': 'Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism', 'timeFrame': 'Measured at baseline and 2, 4 and 6 hours after intake of test meal', 'description': 'Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level'}, {'measure': 'Changes in lipid classes and lipoprotein size', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Changes in plasma and urine metabolomics', 'timeFrame': 'Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase.', 'description': 'Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine.'}, {'measure': 'Check DNA for single nuclear polymorphisms', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Changes in PBMC Whole genome transcriptomics', 'timeFrame': 'Measured at baseline and 4 and 6 hours after intake of test meal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy', 'Familial Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 30 years of age\n* Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:\n\n 1. Untreated\n 2. Treated with low dose statin (\\<20 mg atorvastatin, \\<10-20 mg simvastatin or \\<5-10 mg rosuvastatin)\n 3. Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)\n 4. Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)\n* BMI 18.5 - 30 kg/m2\n* Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)\n\nExclusion Criteria:\n\n* CRP \\>10 mg/L\n* TG \\>4 mmol/L\n* Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism\n* Pregnant or lactating\n* Allergic or intolerant to gluten or egg\n* Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits\n* Using medications affecting lipid metabolism or inflammation, except statins for FH subjects\n* Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))\n* Donating blood 2 months within or during study period\n* Tobacco smoking\n* Large alcohol consumption (\\>40g daily)'}, 'identificationModule': {'nctId': 'NCT02729857', 'briefTitle': 'Postprandial Response After Intake of Meals With Different Fatty Acid Composition', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects', 'orgStudyIdInfo': {'id': '2015/2392/REK sør-øst B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Familial hypercholesterolemia', 'description': 'Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline', 'interventionNames': ['Dietary Supplement: SFA muffin', 'Dietary Supplement: PUFA muffin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy', 'description': 'Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline', 'interventionNames': ['Dietary Supplement: SFA muffin', 'Dietary Supplement: PUFA muffin']}], 'interventions': [{'name': 'SFA muffin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Muffin rich in saturated fat.', 'armGroupLabels': ['Familial hypercholesterolemia', 'Healthy']}, {'name': 'PUFA muffin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Muffin rich in polyunsaturated fat.', 'armGroupLabels': ['Familial hypercholesterolemia', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0317', 'city': 'Oslo', 'state': 'Post Box 1046, Blindern', 'country': 'Norway', 'facility': 'University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Kirsten Bjørklund Holven, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Mills DA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kirsten Holven', 'investigatorAffiliation': 'University of Oslo'}}}}