Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT00655902
Status:
COMPLETED
Last Update Posted:
2011-04-29
First Post:
2008-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Copenhagen Obesity Risk Assessment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044242', 'term': 'Trans Fatty Acids'}, {'id': 'D013024', 'term': 'Soybean Oil'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-09', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in LDL-cholesterol/LDL-cholesterol ratio', 'timeFrame': 'week 0, 8, 16 and 28'}, {'measure': 'Change in Liver fat measured by MR-S', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Change in Insulin sensitivity (ISI composite) from 3h OGTT', 'timeFrame': 'week 0, 8, 16 and 28'}], 'secondaryOutcomes': [{'measure': 'Change in Waist circumference', 'timeFrame': 'week 0, 8, 16 and 28'}, {'measure': 'Change in Visceral adipose tissue measured by MR', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Change in Intramuscular fat measured by MR-S (Psoas Major)', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Change in Body fat percentage measured by DEXA', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Change in 24h heart rate variability measured by Holter-monitoring', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Changes in Cytokines in blood', 'timeFrame': 'week 0, 8, 16 and 28'}, {'measure': 'Changes in Cytokines in abdominal adipose tissue', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Changes in Ceramide in abdominal adipose tissue', 'timeFrame': 'week 0, 16 and 28'}, {'measure': 'Changes in Metabolomic profile in blood and urine', 'timeFrame': 'week 0, 16 and 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trans fat', 'Obesity', 'Insulin sensitivity'], 'conditions': ['Metabolic Syndrome', 'Abdominal Obesity', 'Heart Disease', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '21397284', 'type': 'RESULT', 'citation': 'Bendsen NT, Haugaard SB, Larsen TM, Chabanova E, Stender S, Astrup A. Effect of trans-fatty acid intake on insulin sensitivity and intramuscular lipids--a randomized trial in overweight postmenopausal women. Metabolism. 2011 Jul;60(7):906-13. doi: 10.1016/j.metabol.2011.01.009. Epub 2011 Mar 11.'}, {'pmid': '23154296', 'type': 'RESULT', 'citation': 'Bendsen NT, Chabanova E, Thomsen HS, Larsen TM, Newman JW, Stender S, Dyerberg J, Haugaard SB, Astrup A. Effect of trans fatty acid intake on abdominal and liver fat deposition and blood lipids: a randomized trial in overweight postmenopausal women. Nutr Diabetes. 2011 Jan 31;1(1):e4. doi: 10.1038/nutd.2010.4.'}, {'pmid': '23922748', 'type': 'DERIVED', 'citation': 'Gurdeniz G, Rago D, Bendsen NT, Savorani F, Astrup A, Dragsted LO. Effect of trans fatty acid intake on LC-MS and NMR plasma profiles. PLoS One. 2013 Jul 29;8(7):e69589. doi: 10.1371/journal.pone.0069589. Print 2013.'}, {'pmid': '21795740', 'type': 'DERIVED', 'citation': 'Bendsen NT, Stender S, Szecsi PB, Pedersen SB, Basu S, Hellgren LI, Newman JW, Larsen TM, Haugaard SB, Astrup A. Effect of industrially produced trans fat on markers of systemic inflammation: evidence from a randomized trial in women. J Lipid Res. 2011 Oct;52(10):1821-8. doi: 10.1194/jlr.M014738. Epub 2011 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to assess the effect of a high intake of industrially produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2 diabetes and heart disease in healthy, moderately overweight, postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-70 years\n* BMI 25-32\n* Waist circumference \\> 80 cm\n* Postmenopausal for at least 1 year\n\nExclusion Criteria:\n\n* BP \\> 160/100 mmHg\n* Fasted blood glucose \\> 7 mM\n* Fasted LDL-cholesterol \\> 6 mM\n* Fasted triglycerides \\> 3 mM\n* Diabetes mellitus or other chronic diseases\n* Current or previous cardiovascular disease\n* Weight change \\> 3 kg within last 2 months\n* Use of anti-hypertensive drugs\n* Use of statins/fibrates\n* Use of fish oil supplements\n* Smoking\n* Hard physical activity \\> 10 h/week'}, 'identificationModule': {'nctId': 'NCT00655902', 'acronym': 'COBRA', 'briefTitle': 'Copenhagen Obesity Risk Assessment Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Copenhagen Obesity Risk Assessment Study - A Double Blind Randomized Dietary Intervention Study Examining the Effect of a High Intake of Trans Fatty Acids on Abdominal Obesity and Risk Markers of Type 2 Diabetes and Cardiovascular Disease.', 'orgStudyIdInfo': {'id': 'B237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Trans fat (soy bean oil)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: Control fat (sunflower oil)']}], 'interventions': [{'name': 'Trans fat (soy bean oil)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Industrially produced trans fatty acid from soy bean oil (15 g/d for 16 weeks). The fat (a total of 25 g/d) will be baked into buns.', 'armGroupLabels': ['1']}, {'name': 'Control fat (sunflower oil)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. med, prof. Arne Astrup', 'oldOrganization': 'Department of Human Nutrition, University of Copenhagen'}}}}