Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 2:42 AM
Study NCT ID:
NCT02589769
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2015-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}], 'ancestors': [{'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lipids in normal weight and obese subjects with elevated LDL cholesterol.', 'timeFrame': '10 weeks', 'description': 'Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein in normal weight and obese individuals', 'timeFrame': '10 weeks', 'description': 'Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on c-reactive protein in normal weight and obese individuals'}, {'measure': 'Serum PCSK9 in normal weight and obese individuals', 'timeFrame': '10 weeks', 'description': 'Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on inflammation in normal weight and obese individuals'}, {'measure': 'Fasting glucose and HbA1C', 'timeFrame': '10 weeks', 'description': 'Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on fasting glucose and HbA1C'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Dietary Modification', 'Cardiovascular Risk Factors']}, 'referencesModule': {'references': [{'pmid': '31216575', 'type': 'DERIVED', 'citation': 'Sundfor TM, Svendsen M, Heggen E, Dushanov S, Klemsdal TO, Tonstad S. BMI modifies the effect of dietary fat on atherogenic lipids: a randomized clinical trial. Am J Clin Nutr. 2019 Oct 1;110(4):832-841. doi: 10.1093/ajcn/nqz113.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled clinical trial comparing the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.', 'detailedDescription': 'Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\\>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.\n\nPrimary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.\n\nSecondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\\> 3.0 mmol/l).\n\nExclusion Criteria:\n\n* Diabetes types 1 and 2\n* History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia.\n* Use of statins or other cholesterol-modifying drugs.\n* Genetic lipid disorder.\n* Gastrointestinal disorders that limit food choices.\n* Psychiatric illness, drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT02589769', 'briefTitle': 'Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons', 'orgStudyIdInfo': {'id': '1786 (REK('}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unsaturated fat', 'description': 'an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods', 'interventionNames': ['Other: unsaturated fat for saturated fat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'saturated fat', 'description': 'a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.', 'interventionNames': ['Other: saturated fat']}], 'interventions': [{'name': 'unsaturated fat for saturated fat', 'type': 'OTHER', 'description': 'Substituting unsaturated fat for saturated fat', 'armGroupLabels': ['unsaturated fat']}, {'name': 'saturated fat', 'type': 'OTHER', 'description': 'a control diet with whole fat dairy and meat with saturated fats that are not fat reduced', 'armGroupLabels': ['saturated fat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.Sc in Nutrition', 'investigatorFullName': 'Tine Mejlbo Sundfør', 'investigatorAffiliation': 'Oslo University Hospital'}}}}