Viewing Study NCT01145066

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Ignite Creation Date: 2025-12-24 @ 4:24 PM
Ignite Modification Date: 2025-12-28 @ 9:41 PM
Study NCT ID: NCT01145066
Status: COMPLETED
Last Update Posted: 2019-07-18
First Post: 2010-06-14
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'C051440', 'term': 'lanpol 5'}, {'id': 'D003314', 'term': 'Corn Oil'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mseeds@wakehealth.edu', 'phone': '3367169811', 'title': 'Dr. Michael Seeds', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The diet study was short at only 8 weeks of oil supplementation, it did not control background PUFA consumption by the subjects throught their normal diets, and the population contained subjects at various stages of T2D.'}}, 'adverseEventsModule': {'timeFrame': 'up to 8 weeks', 'description': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'eventGroups': [{'id': 'EG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 4, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sick/virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Upset', 'notes': 'Bloating/constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Upset', 'notes': 'burping/diarrhea/loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weak', 'notes': 'blood sugar varied 1 day or more', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'μIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Fasting insulin data at 4 and 8 weeks was averaged.', 'unitOfMeasure': 'μIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '.85', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '3.19', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Changes in high sensitive C-reactive protein (hsCRP) were assessed.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '.86', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '3.72', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '53.5', 'spread': '6.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '44.2', 'spread': '5.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Data at 4 and 8 weeks was averaged.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'title': 'Cl4:0', 'categories': [{'measurements': [{'value': '.69', 'spread': '.08', 'groupId': 'OG000'}, {'value': '.72', 'spread': '.07', 'groupId': 'OG001'}, {'value': '.70', 'spread': '.07', 'groupId': 'OG002'}]}]}, {'title': 'C14:1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C15:0', 'categories': [{'measurements': [{'value': '.13', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.16', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.15', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C15:1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C16:0', 'categories': [{'measurements': [{'value': '20.64', 'spread': '.41', 'groupId': 'OG000'}, {'value': '21.65', 'spread': '.47', 'groupId': 'OG001'}, {'value': '21.19', 'spread': '.40', 'groupId': 'OG002'}]}]}, {'title': 'C16:1 n-7', 'categories': [{'measurements': [{'value': '1.58', 'spread': '.08', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '.24', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '.13', 'groupId': 'OG002'}]}]}, {'title': 'C17:1', 'categories': [{'measurements': [{'value': '.10', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.13', 'spread': '.03', 'groupId': 'OG001'}, {'value': '.08', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C18:0', 'categories': [{'measurements': [{'value': '7.23', 'spread': '.14', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '.25', 'groupId': 'OG001'}, {'value': '7.47', 'spread': '.09', 'groupId': 'OG002'}]}]}, {'title': 'C18:1', 'categories': [{'measurements': [{'value': '.12', 'spread': '.07', 'groupId': 'OG000'}, {'value': '.17', 'spread': '.06', 'groupId': 'OG001'}, {'value': '.21', 'spread': '.06', 'groupId': 'OG002'}]}]}, {'title': 'C18:1 n-9', 'categories': [{'measurements': [{'value': '19.6', 'spread': '.44', 'groupId': 'OG000'}, {'value': '21.92', 'spread': '.98', 'groupId': 'OG001'}, {'value': '20.63', 'spread': '.96', 'groupId': 'OG002'}]}]}, {'title': 'C18:1 n-11', 'categories': [{'measurements': [{'value': '1.5', 'spread': '.07', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '.06', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '.06', 'groupId': 'OG002'}]}]}, {'title': 'C18:2 n-6 [LA]', 'categories': [{'measurements': [{'value': '32.67', 'spread': '.98', 'groupId': 'OG000'}, {'value': '29.71', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '31.99', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': 'C18:3 n-6 [GLA]', 'categories': [{'measurements': [{'value': '.59', 'spread': '.04', 'groupId': 'OG000'}, {'value': '.55', 'spread': '.05', 'groupId': 'OG001'}, {'value': '.53', 'spread': '.03', 'groupId': 'OG002'}]}]}, {'title': 'C18:3 n-3 [ALA]', 'categories': [{'measurements': [{'value': '.80', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.77', 'spread': '.09', 'groupId': 'OG001'}, {'value': '.73', 'spread': '.06', 'groupId': 'OG002'}]}]}, {'title': 'C18:4 n-3 [SDA]', 'categories': [{'measurements': [{'value': '.01', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.01', 'spread': '.01', 'groupId': 'OG001'}, {'value': '.03', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C20:0', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '.01', 'spread': '.01', 'groupId': 'OG002'}]}]}, {'title': 'C20:1 n-9', 'categories': [{'measurements': [{'value': '.04', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.10', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.08', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C20:2 n-6', 'categories': [{'measurements': [{'value': '.32', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.33', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.30', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C20:3 n-6 [DGLA]', 'categories': [{'measurements': [{'value': '1.51', 'spread': '.08', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '.09', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '.08', 'groupId': 'OG002'}]}]}, {'title': 'C20:4 n-6 [AA]', 'categories': [{'measurements': [{'value': '9.12', 'spread': '.40', 'groupId': 'OG000'}, {'value': '8.68', 'spread': '.40', 'groupId': 'OG001'}, {'value': '8.17', 'spread': '.56', 'groupId': 'OG002'}]}]}, {'title': 'C20:5 n-3 [EPA]', 'categories': [{'measurements': [{'value': '.573', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.56', 'spread': '.07', 'groupId': 'OG001'}, {'value': '.48', 'spread': '.04', 'groupId': 'OG002'}]}]}, {'title': 'C22:0', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C22:1 n-9', 'categories': [{'measurements': [{'value': '.15', 'spread': '.06', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '.05', 'spread': '.04', 'groupId': 'OG002'}]}]}, {'title': 'C22:2 n-6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C22:5 n-3 [DPA]', 'categories': [{'measurements': [{'value': '.55', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.59', 'spread': '.03', 'groupId': 'OG001'}, {'value': '.54', 'spread': '.03', 'groupId': 'OG002'}]}]}, {'title': 'C24:0', 'categories': [{'measurements': [{'value': '.02', 'spread': '.02', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '.02', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C22:6 n-3 [DHA]', 'categories': [{'measurements': [{'value': '1.63', 'spread': '.10', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '.016', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '.12', 'groupId': 'OG002'}]}]}, {'title': 'C24:1 n-9', 'categories': [{'measurements': [{'value': '.01', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.04', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.03', 'spread': '.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'percentage of total fatty acids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Borage and Echium Oil Combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA\n\nborage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA'}, {'id': 'OG001', 'title': 'Fish Oil', 'description': 'Croda 18:12 fish oil\n\nfish oil: 1.6g/day EPA and 1.08g/day DHA'}, {'id': 'OG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}], 'classes': [{'title': 'Cl4:0', 'categories': [{'measurements': [{'value': '.66', 'spread': '.04', 'groupId': 'OG000'}, {'value': '.62', 'spread': '.06', 'groupId': 'OG001'}, {'value': '.66', 'spread': '.05', 'groupId': 'OG002'}]}]}, {'title': 'C14:1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C15:0', 'categories': [{'measurements': [{'value': '.14', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.14', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.14', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C15:1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'C16:0', 'categories': [{'measurements': [{'value': '20.49', 'spread': '.37', 'groupId': 'OG000'}, {'value': '20.76', 'spread': '.39', 'groupId': 'OG001'}, {'value': '20.75', 'spread': '.37', 'groupId': 'OG002'}]}]}, {'title': 'C16:1 n-7', 'categories': [{'measurements': [{'value': '1.39', 'spread': '.08', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '.14', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '.13', 'groupId': 'OG002'}]}]}, {'title': 'C17:1', 'categories': [{'measurements': [{'value': '.05', 'spread': '.02', 'groupId': 'OG000'}, {'value': '.06', 'spread': '.02', 'groupId': 'OG001'}, {'value': '.04', 'spread': '.02', 'groupId': 'OG002'}]}]}, {'title': 'C18:0', 'categories': [{'measurements': [{'value': '7.55', 'spread': '.16', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '.27', 'groupId': 'OG001'}, {'value': '7.62', 'spread': '.12', 'groupId': 'OG002'}]}]}, {'title': 'C18:1', 'categories': [{'measurements': [{'value': '.13', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.25', 'spread': '.06', 'groupId': 'OG001'}, {'value': '.25', 'spread': '.05', 'groupId': 'OG002'}]}]}, {'title': 'C18:1 n-9', 'categories': [{'measurements': [{'value': '19.60', 'spread': '.44', 'groupId': 'OG000'}, {'value': '20.24', 'spread': '.52', 'groupId': 'OG001'}, {'value': '20.30', 'spread': '.61', 'groupId': 'OG002'}]}]}, {'title': 'C18:1 n-11', 'categories': [{'measurements': [{'value': '1.44', 'spread': '.05', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '.06', 'groupId': 'OG001'}, {'value': '1.51', 'spread': '.06', 'groupId': 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DHA'}, {'id': 'BG002', 'title': 'Corn Oil', 'description': 'corn oil: contains 4.5 g/day linoleic acid'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '57.96', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2010-06-14', 'resultsFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-06', 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Insulin', 'timeFrame': 'baseline'}, {'measure': 'Fasting Insulin', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Fasting insulin data at 4 and 8 weeks was averaged.'}, {'measure': 'hsCRP', 'timeFrame': 'baseline', 'description': 'Changes in high sensitive C-reactive protein (hsCRP) were assessed.'}, {'measure': 'hsCRP', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..'}, {'measure': 'Leptin', 'timeFrame': 'baseline'}, {'measure': 'Leptin', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Data at 4 and 8 weeks was averaged.'}], 'secondaryOutcomes': [{'measure': 'Serum Fatty Acids', 'timeFrame': 'baseline'}, {'measure': 'Serum Fatty Acids', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Data at 4 and 8 weeks was averaged.'}, {'measure': 'Pro and Anti-inflammatory Cytokines', 'timeFrame': 'baseline'}, {'measure': 'Pro and Anti-inflammatory Cytokines', 'timeFrame': '4 weeks and 8 weeks combined'}, {'measure': 'Fasting Glucose', 'timeFrame': 'baseline'}, {'measure': 'Fasting Glucose', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Data at 4 and 8 weeks was averaged.'}, {'measure': 'Hemoglobin Levels', 'timeFrame': 'baseline'}, {'measure': 'Hemoglobin Levels', 'timeFrame': '4 weeks and 8 weeks combined', 'description': 'Data at 4 and 8 weeks was averaged.'}, {'measure': 'Adipose Derived Cytokines', 'timeFrame': '4 weeks'}, {'measure': 'PBMC Gene Expression', 'timeFrame': 'baseline'}, {'measure': 'PBMC Gene Expression', 'timeFrame': '4 weeks'}, {'measure': 'SNPs in DNA of Selected Genes', 'timeFrame': 'baseline'}, {'measure': 'SNPs in DNA of Selected Genes', 'timeFrame': '4 weeks'}, {'measure': 'PBMC Leukotriene Stimulation', 'timeFrame': 'baseline'}, {'measure': 'PBMC Leukotriene Stimulation', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'metabolic syndrome', 'inflammation', 'botanical oils'], 'conditions': ['Diabetes', 'Metabolic Syndrome x']}, 'referencesModule': {'references': [{'pmid': '25515553', 'type': 'DERIVED', 'citation': 'Lee TC, Ivester P, Hester AG, Sergeant S, Case LD, Morgan T, Kouba EO, Chilton FH. The impact of polyunsaturated fatty acid-based dietary supplements on disease biomarkers in a metabolic syndrome/diabetes population. Lipids Health Dis. 2014 Dec 16;13:196. doi: 10.1186/1476-511X-13-196.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN medication 5. fasting glucose greater than or equal to 100 mg/dl.\n* participants on statins or glucose lowering drugs if dosages are stable for 3 months\n\nExclusion criteria\n\n* children/young adults less than 21 years of age\n* currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day\n* taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.\n* currently using niacin, fibrates or fish oil\n* blood pressure greater than 170/100\n* HB1Ac greater than 10%\n* TG greater than 500 mg/dl\n* myocardial infarction/vascular surgery/stroke within the past year\n* any stage II,III,IV heart failure\n* prior cholecystectomy\n* end stage renal disease\n* BMI less than 23 or greater than 45\n* pregnancy\n* alcohol use greater than 14 drinks per week\n* current self reported tobacco or illicit drug use\n* intolerance or allergy to fish oil\n* participants taking insulin on QD or BID doses, stable for 3 months'}, 'identificationModule': {'nctId': 'NCT01145066', 'briefTitle': 'Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.', 'orgStudyIdInfo': {'id': 'IRB00007488'}, 'secondaryIdInfos': [{'id': 'P50 AT 0027820', 'type': 'OTHER_GRANT', 'domain': 'NCCAM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'borage and echium oil combination', 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA', 'interventionNames': ['Drug: borage/echium oil combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fish oil', 'description': 'Croda 18:12 fish oil', 'interventionNames': ['Dietary Supplement: fish oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'corn oil', 'interventionNames': ['Dietary Supplement: corn oil']}], 'interventions': [{'name': 'borage/echium oil combination', 'type': 'DRUG', 'otherNames': ['Croda echium oil SR06379', 'Croda borage oil, Crossential GLA TG40'], 'description': 'borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA', 'armGroupLabels': ['borage and echium oil combination']}, {'name': 'fish oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Croda 18:12 fish oil'], 'description': '1.6g/day EPA and 1.08g/day DHA', 'armGroupLabels': ['fish oil']}, {'name': 'corn oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Croda superrefined corn NF'], 'description': 'contains 4.5 g/day linoleic acid', 'armGroupLabels': ['corn oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Floyd(Ski) H Chilton, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}