Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 6:23 PM
Study NCT ID:
NCT02006394
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Dietary Interventions for Treating Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D003314', 'term': 'Corn Oil'}, {'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': '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'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in adipokines', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Fasting plasma adiponectin and leptin'}], 'primaryOutcomes': [{'measure': 'Change in insulin resistance', 'timeFrame': 'Baseline, 6 weeks, and 12 weeks', 'description': 'Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)'}], 'secondaryOutcomes': [{'measure': 'Change in inflammation biomarkers', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Monocytes'], 'conditions': ['Insulin Resistance', 'Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI): 30.0-40.9 kg/m\\^2\n* Metabolic Syndrome\n\nExclusion Criteria:\n\n* Diabetes\n* Inflammatory diseases\n* Eating disorders\n* Pregnancy\n* Known kidney, coronary, gastrointestinal or peripheral artery disease\n* Smoking\n* Recent fish oil (\\>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use\n* Recent weight change\n* Strenuous exercise\n* Fish/food allergies\n* Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use'}, 'identificationModule': {'nctId': 'NCT02006394', 'briefTitle': 'Novel Dietary Interventions for Treating Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'orgStudyIdInfo': {'id': 'IRB #110549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Diet', 'description': 'Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.', 'interventionNames': ['Dietary Supplement: Fish Oil', 'Dietary Supplement: Polyphenol Capsules', 'Other: Reduced glycemic index bread products']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Diet', 'description': 'Market variety bread products, corn oil capsules, and corn starch capsules.', 'interventionNames': ['Dietary Supplement: Corn Oil Capsules', 'Dietary Supplement: Corn starch capsules', 'Other: Market variety bread products']}], 'interventions': [{'name': 'Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'fish oil capsules', 'armGroupLabels': ['Active Diet']}, {'name': 'Polyphenol Capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'delphinidin polyphenol capsules', 'armGroupLabels': ['Active Diet']}, {'name': 'Corn Oil Capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Corn Oil Capsules', 'armGroupLabels': ['Placebo Diet']}, {'name': 'Corn starch capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin capsules', 'armGroupLabels': ['Placebo Diet']}, {'name': 'Reduced glycemic index bread products', 'type': 'OTHER', 'description': 'Made by Zone Labs', 'armGroupLabels': ['Active Diet']}, {'name': 'Market variety bread products', 'type': 'OTHER', 'description': 'placebo bread products', 'armGroupLabels': ['Placebo Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Dorothy Sears, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Dorothy Sears', 'investigatorAffiliation': 'University of California, San Diego'}}}}