Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02211612
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2014-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2014-08-06', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Circulating hormones and molecular analyses in muscle and fat tissue', 'timeFrame': '10 weeks', 'description': 'Serum hormones including prolactin, tyroxin, T3, cortisol, growth hormone, Insulin growth factor-1. Fat cell morphology assessment in fat tissue, and gene and protein expression, DNA methylation analyses in fat and muscle tissue, palmitate tracer uptake in liver using positron emission tomography'}], 'primaryOutcomes': [{'measure': 'Change in lean tissue mass', 'timeFrame': '10 weeks', 'description': 'Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)'}], 'secondaryOutcomes': [{'measure': 'Change in hepatic fat content', 'timeFrame': '10 weeks', 'description': 'Assessed by magnetic resonance imaging (MRI)'}, {'measure': 'Change in visceral adipose tissue (VAT)', 'timeFrame': '10 weeks', 'description': 'Assessed by magnetic resonance imaging (MRI)'}, {'measure': 'Change in total adipose tissue', 'timeFrame': '10 weeks', 'description': 'Assessed by magnetic resonance imaging (MRI)'}, {'measure': 'Change in pancreatic fat', 'timeFrame': '10 weeks', 'description': 'Assessed by MRI'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '10 weeks', 'description': 'Assessed by oral glucose tolerance test (OGTT)'}, {'measure': 'Change in plasma lipids', 'timeFrame': '10 weeks', 'description': 'Plasma cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoprotein B, apolipoprotein A1, free fatty acids, glycerol, proprotein convertase subtilisin/kexin type 9'}, {'measure': 'Change in circulating inflammation and coagulation markers', 'timeFrame': '10 weeks', 'description': 'Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overfeeding', 'Weight gain', 'Liver fat', 'Pancreatic fat', 'Ectopic fat', 'Skeletal muscle', 'Adipose tissue', 'Gene expression', 'DNA methylation', 'Palmitate', 'Linoleic acid', 'Saturated fat', 'Polyunsaturated fat', 'Metabolism', 'Insulin sensitivity'], 'conditions': ['Obesity', 'Overfeeding', 'Muscle Mass', 'Body Composition', 'Ectopic Fat']}, 'referencesModule': {'references': [{'pmid': '38636844', 'type': 'DERIVED', 'citation': 'Rosqvist F, Cedernaes J, Martinez Mora A, Friden M, Johansson HE, Iggman D, Larsson A, Ahlstrom H, Kullberg J, Riserus U. Overfeeding polyunsaturated fat compared with saturated fat does not differentially influence lean tissue accumulation in individuals with overweight: a randomized controlled trial. Am J Clin Nutr. 2024 Jul;120(1):121-128. doi: 10.1016/j.ajcnut.2024.04.010. Epub 2024 Apr 16.'}, {'pmid': '33344496', 'type': 'DERIVED', 'citation': 'Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.'}, {'pmid': '31369090', 'type': 'DERIVED', 'citation': 'Rosqvist F, Kullberg J, Stahlman M, Cedernaes J, Heurling K, Johansson HE, Iggman D, Wilking H, Larsson A, Eriksson O, Johansson L, Straniero S, Rudling M, Antoni G, Lubberink M, Orho-Melander M, Boren J, Ahlstrom H, Riserus U. Overeating Saturated Fat Promotes Fatty Liver and Ceramides Compared With Polyunsaturated Fat: A Randomized Trial. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6207-6219. doi: 10.1210/jc.2019-00160.'}]}, 'descriptionModule': {'briefSummary': 'To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 25-32\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* Type 1 diabetes\n* Kidney disease\n* Liver disease\n* Abnormal clinical chemistry at screening\n* Intense physical exercise \\> 2 hours per week\n* Use of statins or drugs affecting energy metabolism\n* Use of extreme diets'}, 'identificationModule': {'nctId': 'NCT02211612', 'acronym': 'LIPOGAIN-2', 'briefTitle': 'Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)', 'orgStudyIdInfo': {'id': 'LIPOGAIN-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saturated fatty acids (SFA)-group', 'description': 'Weight gain created by addition of muffins baked on saturated fat', 'interventionNames': ['Dietary Supplement: SFA-group']}, {'type': 'EXPERIMENTAL', 'label': 'Polyunsaturated fatty acids (PUFA)-group', 'description': 'Weight gain created by addition of muffins baked on polyunsaturated fat', 'interventionNames': ['Dietary Supplement: PUFA-group']}], 'interventions': [{'name': 'PUFA-group', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Polyunsaturated fatty acids (PUFA)-group']}, {'name': 'SFA-group', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Saturated fatty acids (SFA)-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'state': 'Please Select', 'country': 'Sweden', 'facility': 'Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Ulf Riserus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'David Iggman', 'investigatorAffiliation': 'Uppsala University'}}}}