Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 10:54 AM
Study NCT ID:
NCT01617304
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2012-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Food Cooking on Diabetes-2 Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in HOMA from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks', 'description': 'insulin sensitivity'}, {'measure': 'change in OGTT from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks at 0 and 120 min', 'description': 'insulin sensitivity'}, {'measure': 'change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}, {'measure': 'change in plasma and urin AGEs from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}, {'measure': 'change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}, {'measure': 'change in metabolomics dats from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}, {'measure': 'change in AGE levels in skin from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}], 'secondaryOutcomes': [{'measure': 'change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}, {'measure': 'change in HbA1c from baseline to 4 weeks', 'timeFrame': '0 and 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['advanced glycation end products', 'insulin sensitivity', 'obesity', 'inflammation', 'metabolomics', 'appetite', 'CVD'], 'conditions': ['Obesity', 'Type 2 Diabetes', 'Insulin Resistance', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women, healthy between 20 and 50 y\n* BMI between 25 and 40 kg/m2\n* weight circumference over 88 cm\n\nExclusion Criteria:\n\n* weigh changes within the last 2 months more than +/- 3 kg\n* Physical activity more than 8 h per week\n* smoking\n* medications and supplements\n* being vegetarian or vegan\n* pregnancy or breast feeding\n* postmenopause\n* chronic disease\n* previous gastric bypass surgery\n* blood donation within the last 3 months\n* Involvement in other clinical trials\n* allergic to paraaminobenzoic acid'}, 'identificationModule': {'nctId': 'NCT01617304', 'acronym': 'Age-2', 'briefTitle': 'Effects of Food Cooking on Diabetes-2 Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'orgStudyIdInfo': {'id': 'M201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low AGE, glucose', 'description': 'Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'low AGE, fructose', 'description': 'Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'high AGE, fructose', 'description': 'Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'high AGE, glucose', 'description': 'Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution', 'interventionNames': ['Other: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'OTHER', 'description': 'Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution', 'armGroupLabels': ['high AGE, fructose', 'high AGE, glucose', 'low AGE, fructose', 'low AGE, glucose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Susanne G Bugel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'AAstrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}