Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-31 @ 2:33 AM
Study NCT ID:
NCT02114892
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2014-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'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': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'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': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '+52-33-10-58-52-00', 'title': 'Dr. Manuel González Ortiz', 'phoneExt': '34212', 'organization': 'Institute of Experimental andl Clinical Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study', 'eventGroups': [{'id': 'EG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg', 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Triglycerides Levels at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '210.6', 'spread': '63.3', 'groupId': 'OG000'}, {'value': '235.8', 'spread': '148.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'High Density Lipoprotein (c-HDL) Levels at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline. Week 12', 'description': 'The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Fasting Glucose Levels at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '116.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '121.7', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1019.7', 'spread': '335.1', 'groupId': 'OG000'}, {'value': '1279.3', 'spread': '599.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '.28', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '.60', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Total Insulin Sensitivity at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Weight at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Body Mass Index at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '203.4', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '208.9', 'spread': '27.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.946', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoproteins (c-LDL) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '122.3', 'spread': '39.2', 'groupId': 'OG000'}, {'value': '126.8', 'spread': '33.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.365', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Creatinine at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '57.94', 'spread': '14.20', 'groupId': 'OG000'}, {'value': '63.29', 'spread': '11.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.557', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline. Week 12.', 'description': 'The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12', 'unitOfMeasure': 'µmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Uric Acid at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '277.93', 'spread': '38.72', 'groupId': 'OG000'}, {'value': '364.03', 'spread': '67.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12', 'unitOfMeasure': 'µmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Waist Circumference at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '105.4', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '105.8', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Diastolic Blood Pressure at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '78.1', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient did not complete the study due to early withdrawl', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'Two patients did not complete the study due to early withdrawl', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days\n\nResveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days\n\nPlacebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.75', 'spread': '5.38', 'groupId': 'BG000'}, {'value': '40.33', 'spread': '5.41', 'groupId': 'BG001'}, {'value': '40.04', 'spread': '5.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '91.0', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '92.71', 'spread': '11.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.67', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '164.33', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '163.50', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Height was measured with subjects standing and the measurements were round to the nearest centimeter.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '35.56', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '33.73', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '34.65', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat Mass', 'classes': [{'categories': [{'measurements': [{'value': '41.18', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '36.13', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '38.66', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Fat mass was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '109.83', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '104.50', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '107.17', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '119.96', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '116.03', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '117.99', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '78.36', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '77.15', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '77.76', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 0'", 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '4.95', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2500 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 30'", 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 60'", 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 90'", 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 120'", 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '206.0', 'spread': '32.0', 'groupId': 'BG000'}, {'value': '195.4', 'spread': '34.8', 'groupId': 'BG001'}, {'value': '200.7', 'spread': '33.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '254.3', 'spread': '55.6', 'groupId': 'BG000'}, {'value': '233.8', 'spread': '77.7', 'groupId': 'BG001'}, {'value': '244.0', 'spread': '66.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL-c', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-c', 'classes': [{'categories': [{'measurements': [{'value': '120.7', 'spread': '32.0', 'groupId': 'BG000'}, {'value': '119.8', 'spread': '46.5', 'groupId': 'BG001'}, {'value': '120.2', 'spread': '39.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC glucose', 'classes': [{'categories': [{'measurements': [{'value': '935.8', 'spread': '188.6', 'groupId': 'BG000'}, {'value': '950.8', 'spread': '167.6', 'groupId': 'BG001'}, {'value': '943.3', 'spread': '174.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.', 'unitOfMeasure': 'mmol*h/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC insuline', 'classes': [{'categories': [{'measurements': [{'value': '48418.5', 'spread': '22707.4', 'groupId': 'BG000'}, {'value': '62955.8', 'spread': '37620.0', 'groupId': 'BG001'}, {'value': '55687.1', 'spread': '31282.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.', 'unitOfMeasure': 'pmol*h/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '0.22', 'groupId': 'BG000'}, {'value': '0.59', 'spread': '0.29', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First phase of insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '1256.6', 'spread': '601.5', 'groupId': 'BG000'}, {'value': '1440.0', 'spread': '619.8', 'groupId': 'BG001'}, {'value': '1348.3', 'spread': '604.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0')", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "Sample size was calculated in accordance of Jeyaseelan's clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2014-04-11', 'resultsFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-04-11', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-16', 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglycerides Levels at Week 12', 'timeFrame': 'Week 12', 'description': 'The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12'}, {'measure': 'High Density Lipoprotein (c-HDL) Levels at Week 12.', 'timeFrame': 'Baseline. Week 12', 'description': 'The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12'}, {'measure': 'Fasting Glucose Levels at Week 12.', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12'}, {'measure': 'Systolic Blood Pressure at Week 12.', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12'}, {'measure': 'First Phase of Insulin Secretion at Week 12.', 'timeFrame': 'Week 12', 'description': 'The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12'}, {'measure': 'Total Insulin Secretion at Week 12.', 'timeFrame': 'Week 12', 'description': 'The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12'}, {'measure': 'Total Insulin Sensitivity at Week 12.', 'timeFrame': 'Week 12', 'description': 'The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12'}, {'measure': 'Waist Circumference at Week 12', 'timeFrame': 'Week 12', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12'}, {'measure': 'Diastolic Blood Pressure at Week 12', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12'}], 'secondaryOutcomes': [{'measure': 'Weight at Week 12.', 'timeFrame': 'Week 12', 'description': 'The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12'}, {'measure': 'Body Mass Index at Week 12', 'timeFrame': 'Week 12', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12'}, {'measure': 'Total Cholesterol at Week 12', 'timeFrame': 'Week 12', 'description': 'The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12'}, {'measure': 'Low Density Lipoproteins (c-LDL) at Week 12', 'timeFrame': 'Week 12', 'description': 'The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12'}, {'measure': 'Creatinine at Week 12.', 'timeFrame': 'Baseline. Week 12.', 'description': 'The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12'}, {'measure': 'Uric Acid at Week 12.', 'timeFrame': 'Week 12.', 'description': 'The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'central obesity', 'resveratrol', 'insulin secretion', 'insulin sensitivity'], 'conditions': ['Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '20823772', 'type': 'BACKGROUND', 'citation': 'Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. doi: 10.1097/MCO.0b013e32833ef291.'}, {'pmid': '20303945', 'type': 'BACKGROUND', 'citation': 'Szkudelska K, Szkudelski T. Resveratrol, obesity and diabetes. Eur J Pharmacol. 2010 Jun 10;635(1-3):1-8. doi: 10.1016/j.ejphar.2010.02.054. Epub 2010 Mar 19.'}, {'pmid': '16732220', 'type': 'BACKGROUND', 'citation': 'Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. doi: 10.1038/nrd2060. Epub 2006 May 26.'}, {'pmid': '22436213', 'type': 'BACKGROUND', 'citation': 'Timmers S, Auwerx J, Schrauwen P. The journey of resveratrol from yeast to human. Aging (Albany NY). 2012 Mar;4(3):146-58. doi: 10.18632/aging.100445.'}, {'pmid': '20491649', 'type': 'BACKGROUND', 'citation': 'Kroon PA, Iyer A, Chunduri P, Chan V, Brown L. The Cardiovascular Nutrapharmacology of Resveratrol: Pharmacokinetics, Molecular Mechanisms and Therapeutic Potential. Curr Med Chem. 2010;17(23):2442-55. doi: 10.2174/092986710791556032.'}, {'pmid': '20219519', 'type': 'BACKGROUND', 'citation': 'Baur JA. Resveratrol, sirtuins, and the promise of a DR mimetic. Mech Ageing Dev. 2010 Apr;131(4):261-9. doi: 10.1016/j.mad.2010.02.007. Epub 2010 Feb 26.'}, {'pmid': '21261639', 'type': 'BACKGROUND', 'citation': 'Szkudelski T, Szkudelska K. Anti-diabetic effects of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:34-9. doi: 10.1111/j.1749-6632.2010.05844.x.'}, {'pmid': '16626303', 'type': 'RESULT', 'citation': 'Zhang J. Resveratrol inhibits insulin responses in a SirT1-independent pathway. Biochem J. 2006 Aug 1;397(3):519-27. doi: 10.1042/BJ20050977.'}, {'pmid': '19100718', 'type': 'RESULT', 'citation': 'Rivera L, Moron R, Zarzuelo A, Galisteo M. Long-term resveratrol administration reduces metabolic disturbances and lowers blood pressure in obese Zucker rats. Biochem Pharmacol. 2009 Mar 15;77(6):1053-63. doi: 10.1016/j.bcp.2008.11.027. 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Epub 2006 Nov 1.'}, {'pmid': '20463039', 'type': 'RESULT', 'citation': 'Fischer-Posovszky P, Kukulus V, Tews D, Unterkircher T, Debatin KM, Fulda S, Wabitsch M. Resveratrol regulates human adipocyte number and function in a Sirt1-dependent manner. Am J Clin Nutr. 2010 Jul;92(1):5-15. doi: 10.3945/ajcn.2009.28435. Epub 2010 May 12.'}, {'pmid': '21261640', 'type': 'RESULT', 'citation': 'Baile CA, Yang JY, Rayalam S, Hartzell DL, Lai CY, Andersen C, Della-Fera MA. Effect of resveratrol on fat mobilization. Ann N Y Acad Sci. 2011 Jan;1215:40-7. doi: 10.1111/j.1749-6632.2010.05845.x.'}, {'pmid': '21569266', 'type': 'RESULT', 'citation': 'Alberdi G, Rodriguez VM, Miranda J, Macarulla MT, Arias N, Andres-Lacueva C, Portillo MP. Changes in white adipose tissue metabolism induced by resveratrol in rats. 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Epub 2007 Jun 19.'}, {'pmid': '17112576', 'type': 'RESULT', 'citation': 'Lagouge M, Argmann C, Gerhart-Hines Z, Meziane H, Lerin C, Daussin F, Messadeq N, Milne J, Lambert P, Elliott P, Geny B, Laakso M, Puigserver P, Auwerx J. Resveratrol improves mitochondrial function and protects against metabolic disease by activating SIRT1 and PGC-1alpha. Cell. 2006 Dec 15;127(6):1109-22. doi: 10.1016/j.cell.2006.11.013. Epub 2006 Nov 16.'}, {'pmid': '18266981', 'type': 'RESULT', 'citation': 'Penumathsa SV, Thirunavukkarasu M, Zhan L, Maulik G, Menon VP, Bagchi D, Maulik N. Resveratrol enhances GLUT-4 translocation to the caveolar lipid raft fractions through AMPK/Akt/eNOS signalling pathway in diabetic myocardium. J Cell Mol Med. 2008 Dec;12(6A):2350-61. doi: 10.1111/j.1582-4934.2008.00251.x.'}, {'pmid': '21673955', 'type': 'RESULT', 'citation': 'Dao TM, Waget A, Klopp P, Serino M, Vachoux C, Pechere L, Drucker DJ, Champion S, Barthelemy S, Barra Y, Burcelin R, Seree E. Resveratrol increases glucose induced GLP-1 secretion in mice: a mechanism which contributes to the glycemic control. PLoS One. 2011;6(6):e20700. doi: 10.1371/journal.pone.0020700. Epub 2011 Jun 6.'}, {'pmid': '21385509', 'type': 'RESULT', 'citation': 'Brasnyo P, Molnar GA, Mohas M, Marko L, Laczy B, Cseh J, Mikolas E, Szijarto IA, Merei A, Halmai R, Meszaros LG, Sumegi B, Wittmann I. Resveratrol improves insulin sensitivity, reduces oxidative stress and activates the Akt pathway in type 2 diabetic patients. Br J Nutr. 2011 Aug;106(3):383-9. doi: 10.1017/S0007114511000316. Epub 2011 Mar 9.'}, {'pmid': '22219517', 'type': 'RESULT', 'citation': 'Crandall JP, Oram V, Trandafirescu G, Reid M, Kishore P, Hawkins M, Cohen HW, Barzilai N. Pilot study of resveratrol in older adults with impaired glucose tolerance. J Gerontol A Biol Sci Med Sci. 2012 Dec;67(12):1307-12. doi: 10.1093/gerona/glr235. Epub 2012 Jan 4.'}, {'pmid': '17069794', 'type': 'RESULT', 'citation': 'Szkudelski T. Resveratrol inhibits insulin secretion from rat pancreatic islets. Eur J Pharmacol. 2006 Dec 15;552(1-3):176-81. doi: 10.1016/j.ejphar.2006.09.046. Epub 2006 Sep 27.'}]}, 'descriptionModule': {'briefSummary': "The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.\n\nResveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.\n\nThe aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.\n\nThe investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.", 'detailedDescription': 'A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.\n\n12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.\n\nThe remaining 12 patients received placebo with the same prescription.\n\nArea Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).\n\nThis protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.\n\nResults are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients both sexes\n* Age between 30 and 50 years\n* Metabolic Syndrome according to the IDF criteria\n* Waist circumference\n* Man ≥90 cm\n* Woman ≥80 cm\n* And two of the following criteria:\n* High density lipoprotein\n* Man ≤40 mg/dL\n* Woman ≤50 mg/dL\n* Fasting glucose ≥100 mg/dL\n* Triglycerides ≥150 mg/dL\n* Blood pressure ≥130/85 mmHg\n* Informed consent signed\n\nExclusion Criteria:\n\n* Women with confirmed or suspected pregnancy\n* Women under lactation and/or puerperium\n* Hypersensibility to resveratrol\n* Physical impossibility for taking pills\n* Known uncontrolled renal, hepatic, heart or thyroid diseased\n* Previous treatment for the metabolic syndrome components\n* Body Mass Index ≥39.9 kg/m2\n* Fasting glucose ≥126 mg/dL\n* Triglycerides ≥500 mg/dL\n* Total cholesterol ≥240 mg/dL\n* Low density lipoprotein (c-LDL) ≥190 mg/dL\n* Blood Pressure ≥140/90 mmHg'}, 'identificationModule': {'nctId': 'NCT02114892', 'briefTitle': 'Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion', 'orgStudyIdInfo': {'id': 'RESV-MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resveratrol', 'description': 'Resveratrol capsules, 500 mg, three times per day before meals during 90 days', 'interventionNames': ['Drug: Resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Resveratrol', 'type': 'DRUG', 'otherNames': ['Trans resveratrol', "3, 5, 4' -trihidroxiestilbeno"], 'description': 'Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.', 'armGroupLabels': ['Resveratrol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Calcined magnesia'], 'description': 'Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45037', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'MANUEL GONZALEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Manuel González Ortiz', 'investigatorAffiliation': 'University of Guadalajara'}}}}