Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 6:48 PM
Study NCT ID:
NCT01215903
Status:
COMPLETED
Last Update Posted:
2010-10-25
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-22', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'At 8 weeks'}, {'measure': 'Plasma lipids and lipoproteins', 'timeFrame': 'at 8 weeks'}, {'measure': 'Blood pressure', 'timeFrame': 'At 8 weeks'}, {'measure': 'Plasma and serum inflammatory markers', 'timeFrame': 'At 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Glucose tolerance', 'timeFrame': 'At 8 weeks'}, {'measure': 'Energy intake', 'timeFrame': 'At 8 weeks'}, {'measure': 'Fatty acids of phospholipids in skeletal muscle', 'timeFrame': 'At 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.', 'detailedDescription': 'An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight or obese (body mass index \\[BMI\\] between 25 and 40kg/m2)\n* fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L\n* fasting plasma insulin above 90pmol/L\n\nExclusion Criteria:\n\n* Diabetes, chronic, metabolic or acute disease\n* Major surgery within the last 3 months\n* Significant weight loss (±10%) within the last 6 months\n* Any medication-taking known to affect lipid of glucose metabolism\n* Allergy, intolerance or dislike of fish\n* Smokers'}, 'identificationModule': {'nctId': 'NCT01215903', 'briefTitle': 'Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile', 'orgStudyIdInfo': {'id': 'SIRUL-85742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish gelatin and omega-3', 'interventionNames': ['Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid']}, {'type': 'EXPERIMENTAL', 'label': 'Omega-3', 'interventionNames': ['Dietary Supplement: Omega-3 polyunsaturated fatty acid']}], 'interventions': [{'name': 'Fish gelatin and omega-3 polyunsaturated fatty acid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish gelatin and omega-3']}, {'name': 'Omega-3 polyunsaturated fatty acid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Omega-3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Laval University', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Helene Jacques, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}, {'name': 'Andre Marette, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}, {'name': 'John S Weisnagel, MD/FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Advance Foods and Materials Network', 'class': 'OTHER'}, {'name': 'Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)', 'class': 'UNKNOWN'}, {'name': 'University of Guelph', 'class': 'OTHER'}, {'name': 'Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements)', 'class': 'UNKNOWN'}, {'name': 'Kenney & Ross', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Helene Jacques, PhD', 'oldOrganization': 'Laval University'}}}}