Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-11 @ 11:44 PM
Study NCT ID:
NCT02621060
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002726', 'term': 'Chlorogenic Acid'}], 'ancestors': [{'id': 'D002934', 'term': 'Cinnamates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esperanzamartnezabundi@yahoo.com', 'phone': '+52-33-10-58-52-00', 'title': 'Dra. Esperanza Martínez Abundis', 'phoneExt': '34211', 'organization': 'Institute of Experimental and Clinical Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected thoughtout the 90 days of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Headacha', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12.', 'description': 'Reflect the fasting glucose level after a 10- to 12-h overnight fast.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'PRIMARY', 'title': '2 Hours Plasma Glucose (2-h PG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.084', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'PRIMARY', 'title': 'Glycated Hemoglobin A1c (A1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.755', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': "Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.", 'unitOfMeasure': 'Percentage of A1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '1281', 'spread': '818', 'groupId': 'OG000'}, {'value': '1133', 'spread': '601', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.084', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'After intervention with Stumvoll index', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'After intervention Matsuda Index', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve of Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '1187', 'spread': '130', 'groupId': 'OG000'}, {'value': '1145', 'spread': '199', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Area under the curve of glucose was obtained using the trapezoidal integration.', 'unitOfMeasure': 'mmol/l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '67,322', 'spread': '31,531', 'groupId': 'OG000'}, {'value': '72,857', 'spread': '29,414', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention area under the curve of insulin', 'unitOfMeasure': 'pmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '80.8', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], '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/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist Circumference (WC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'spread': '5', 'groupId': 'OG000'}, {'value': '104', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '05', 'paramValue': '0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '9', 'groupId': 'OG000'}, {'value': '113', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Plessure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '7', 'groupId': 'OG000'}, {'value': '74', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Triglycerides (TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Very-low Density Lipoprotein (VLDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The VLDL 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': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Glutamic Pyruvic Transaminase (GPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '25.25', 'spread': '13.46', 'groupId': 'OG000'}, {'value': '22.64', 'spread': '15.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention by spectrophotometry', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Glutamic Oxaloacetic Transaminase (GOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '22.03', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '17.79', 'spread': '8.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.472', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention by spectrophotometry', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.774', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12.', 'description': 'The creatinine 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': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'OG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.637', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 creatinina levels at week 12.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'FG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nPlacebo: Placebo: 1200 mg per day for three months'}, {'id': 'BG001', 'title': 'Chlorogenic Acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.\n\nChlorogenic acid: Chologenic acid: 1200 mg per day for three months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '9', 'groupId': 'BG000'}, {'value': '43', 'spread': '11', 'groupId': 'BG001'}, {'value': '44', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'spread': '8', 'groupId': 'BG000'}, {'value': '83.3', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '82.3', 'spread': '8.9', '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': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '7', 'groupId': 'BG000'}, {'value': '106', 'spread': '10', 'groupId': 'BG001'}, {'value': '105', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Waist circumference was measured with a flexible tape in them id point 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': '120', 'spread': '6', 'groupId': 'BG000'}, {'value': '115', 'spread': '11', 'groupId': 'BG001'}, {'value': '117', 'spread': '9', '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 diastolic blood pressure (DBP). The value was expressed on mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '6', 'groupId': 'BG000'}, {'value': '77', 'spread': '11', 'groupId': 'BG001'}, {'value': '77', 'spread': '9', '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 diastolic blood pressure (DBP). The value was expressed on mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of fasting plasma glucose (FPG), was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour plasma glucose', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of 2-hour plasma glcuose (2-h PG), was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of triglycerides (TG), was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of total cholesterol (TC) , was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very low-density lipoprotein (VLDL)', 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.36', 'groupId': 'BG000'}, {'value': '0.72', 'spread': '0.30', 'groupId': 'BG001'}, {'value': '0.75', 'spread': '0.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glutamic oxaloacetic transaminase (GOT)', 'classes': [{'categories': [{'measurements': [{'value': '21.46', 'spread': '14.72', 'groupId': 'BG000'}, {'value': '18.16', 'spread': '5.92', 'groupId': 'BG001'}, {'value': '19.81', 'spread': '11.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glutamic pyruvic transaminase (GPT)', 'classes': [{'categories': [{'measurements': [{'value': '24.25', 'spread': '8.51', 'groupId': 'BG000'}, {'value': '20.93', 'spread': '9.73', 'groupId': 'BG001'}, {'value': '23.02', 'spread': '10.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.02', 'groupId': 'BG000'}, {'value': '0.05', 'spread': '0.02', 'groupId': 'BG001'}, {'value': '0.05', 'spread': '0.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric Acid', 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.06', 'groupId': 'BG000'}, {'value': '0.29', 'spread': '0.05', 'groupId': 'BG001'}, {'value': '0.3', 'spread': '0.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve of glucose (AUCG)', 'classes': [{'categories': [{'measurements': [{'value': '1139', 'spread': '154', 'groupId': 'BG000'}, {'value': '1119', 'spread': '147', 'groupId': 'BG001'}, {'value': '1129', 'spread': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve of glucose was obtained using the trapezoidal integration.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve of insulin (AUCI)', 'classes': [{'categories': [{'measurements': [{'value': '72,298', 'spread': '24,627', 'groupId': 'BG000'}, {'value': '76,993', 'spread': '26,480', 'groupId': 'BG001'}, {'value': '74,645', 'spread': '25,238', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve of insulin was obtained using the trapezoidal integration.', 'unitOfMeasure': 'pmol/L/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.21', 'groupId': 'BG000'}, {'value': '0.71', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '0.65', 'spread': '0.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).', 'unitOfMeasure': 'Unitless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First phase of insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '1248', 'spread': '701', 'groupId': 'BG000'}, {'value': '1331', 'spread': '628', 'groupId': 'BG001'}, {'value': '1289', 'spread': '655', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated by Stumvoll index \\[1283 + 1.829 · insulin 30 min (pmol/L) -138.7 · glucose 30 min (mmol/L) + 3.772 · insulin 0 min (pmol/L)\\]', 'unitOfMeasure': 'Unitless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '2.17', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '1.98', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '2.07', 'spread': '0.79', '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': 'Unitless', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-08', 'studyFirstSubmitDate': '2015-12-01', 'resultsFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-08', 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 12.', 'description': 'Reflect the fasting glucose level after a 10- to 12-h overnight fast.'}, {'measure': '2 Hours Plasma Glucose (2-h PG)', 'timeFrame': 'Week 12.', 'description': 'Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.'}, {'measure': 'Glycated Hemoglobin A1c (A1C)', 'timeFrame': 'Week 12.', 'description': "Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance."}, {'measure': 'Total Insulin Secretion', 'timeFrame': 'Week 12.', 'description': 'After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).'}, {'measure': 'First Phase of Insulin Secretion', 'timeFrame': 'Week 12.', 'description': 'After intervention with Stumvoll index'}, {'measure': 'Insulin Sensitivity', 'timeFrame': 'Week 12.', 'description': 'After intervention Matsuda Index'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve of Glucose', 'timeFrame': 'Week 12.', 'description': 'Area under the curve of glucose was obtained using the trapezoidal integration.'}, {'measure': 'Area Under the Curve of Insulin', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention area under the curve of insulin'}, {'measure': 'Body Weight', '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', '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': 'Waist Circumference (WC)', 'timeFrame': 'Week 12.', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12'}, {'measure': 'Systolic Blood Pressure (SBP)', '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 blood pressure at week 12'}, {'measure': 'Diastolic Blood Plessure (DBP)', 'timeFrame': 'Week 12.', 'description': 'The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}, {'measure': 'Triglycerides (TG)', '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': 'Total Cholesterol (TC)', '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': 'High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Week 12.', 'description': 'The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12'}, {'measure': 'Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Week 12.', 'description': 'The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12'}, {'measure': 'Very-low Density Lipoprotein (VLDL)', 'timeFrame': 'Week 12.', 'description': 'The VLDL 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': 'Glutamic Pyruvic Transaminase (GPT)', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention by spectrophotometry'}, {'measure': 'Glutamic Oxaloacetic Transaminase (GOT)', 'timeFrame': 'Week 12.', 'description': 'Before and after intervention by spectrophotometry'}, {'measure': 'Creatinine', 'timeFrame': 'Week 12.', 'description': 'The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12'}, {'measure': 'Uric Acid', '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 creatinina levels at week 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chlorogenic acid', 'Control glucose', 'Insulin Secretion', 'Insulin Sensitivity'], 'conditions': ['Impaired Glucose Tolerance']}, 'referencesModule': {'references': [{'pmid': '16551305', 'type': 'BACKGROUND', 'citation': 'van Popele NM, Elizabeth Hak A, Mattace-Raso FU, Bots ML, van der Kuip DA, Reneman RS, Hoeks AP, Hofman A, Grobbee DE, Witteman JC. Impaired fasting glucose is associated with increased arterial stiffness in elderly people without diabetes mellitus: the Rotterdam Study. J Am Geriatr Soc. 2006 Mar;54(3):397-404. doi: 10.1111/j.1532-5415.2005.00614.x.'}, {'pmid': '10097917', 'type': 'BACKGROUND', 'citation': 'Shaw JE, Zimmet PZ, de Courten M, Dowse GK, Chitson P, Gareeboo H, Hemraj F, Fareed D, Tuomilehto J, Alberti KG. Impaired fasting glucose or impaired glucose tolerance. What best predicts future diabetes in Mauritius? Diabetes Care. 1999 Mar;22(3):399-402. doi: 10.2337/diacare.22.3.399.'}, {'pmid': '18996826', 'type': 'BACKGROUND', 'citation': 'Garber AJ, Handelsman Y, Einhorn D, Bergman DA, Bloomgarden ZT, Fonseca V, Garvey WT, Gavin JR 3rd, Grunberger G, Horton ES, Jellinger PS, Jones KL, Lebovitz H, Levy P, McGuire DK, Moghissi ES, Nesto RW. Diagnosis and management of prediabetes in the continuum of hyperglycemia: when do the risks of diabetes begin? A consensus statement from the American College of Endocrinology and the American Association of Clinical Endocrinologists. Endocr Pract. 2008 Oct;14(7):933-46. doi: 10.4158/EP.14.7.933. No abstract available.'}, {'pmid': '22079683', 'type': 'BACKGROUND', 'citation': 'Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.'}, {'pmid': '23598536', 'type': 'BACKGROUND', 'citation': 'Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013 Mar-Apr;19(2):327-36. doi: 10.4158/endp.19.2.a38267720403k242. No abstract available.'}, {'pmid': '18370832', 'type': 'BACKGROUND', 'citation': 'Guerrero-Romero F, Rodriguez-Moran M, Perez-Fuentes R, Sanchez-Guillen MC, Gonzalez-Ortiz M, Martinez-Abundis E, Brito-Zurita O, Madero A, Figueroa B, Revilla-Monsalve C, Flores-Martinez SE, Islas-Andrade S, Rascon-Pacheco RA, Cruz M, Sanchez-Corona J. Prediabetes and its relationship with obesity in Mexican adults: The Mexican Diabetes Prevention (MexDiab) Study. Metab Syndr Relat Disord. 2008 Mar;6(1):15-23. doi: 10.1089/met.2007.0020.'}, {'pmid': '25897193', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.'}, {'pmid': '17364278', 'type': 'BACKGROUND', 'citation': 'Adeney KL, Williams MA, Schiff MA, Qiu C, Sorensen TK. Coffee consumption and the risk of gestational diabetes mellitus. Acta Obstet Gynecol Scand. 2007;86(2):161-6. doi: 10.1080/00016340600994992.'}, {'pmid': '15694706', 'type': 'BACKGROUND', 'citation': 'McCarty MF. A chlorogenic acid-induced increase in GLP-1 production may mediate the impact of heavy coffee consumption on diabetes risk. Med Hypotheses. 2005;64(4):848-53. doi: 10.1016/j.mehy.2004.03.037.'}, {'pmid': '11208940', 'type': 'BACKGROUND', 'citation': 'Olthof MR, Hollman PC, Katan MB. Chlorogenic acid and caffeic acid are absorbed in humans. J Nutr. 2001 Jan;131(1):66-71. doi: 10.1093/jn/131.1.66.'}, {'pmid': '24039147', 'type': 'BACKGROUND', 'citation': 'Renouf M, Marmet C, Giuffrida F, Lepage M, Barron D, Beaumont M, Williamson G, Dionisi F. Dose-response plasma appearance of coffee chlorogenic and phenolic acids in adults. Mol Nutr Food Res. 2014 Feb;58(2):301-9. doi: 10.1002/mnfr.201300349. Epub 2013 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.\n\nWere calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 30.0-34.99 kg / m2.\n* Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.\n* Written informed consent.\n* Body weight stable over the last 3 months.\n* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.\n* Women who are not contemplated get pregnant within the next 6 months.\n\nExclusion Criteria:\n\n* Women pregnant or breastfeeding.\n* Physical or mental disability that makes it impossible to perform the intervention.\n* Diagnosis of Hypertension or heart failure.\n* Smokers.\n* Untreated thyroid disease.\n* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).\n* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.\n* Diagnosis of renal disease or creatinine \\> 1.5 mg / dl.\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.\n* Total Cholesterol ≥ 280 mg/dL.\n* Triglycerids ≥ 300 mg/dL.\n* Known allergy to calcined magnesia or Chorogenic acid.'}, 'identificationModule': {'nctId': 'NCT02621060', 'briefTitle': 'Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance', 'orgStudyIdInfo': {'id': 'CT-ACG-271281-LYZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorogenic acid', 'description': '1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.', 'interventionNames': ['Drug: Chlorogenic acid']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Calcined magnesia'], 'description': 'Placebo: 1200 mg per day for three months', 'armGroupLabels': ['Placebo']}, {'name': 'Chlorogenic acid', 'type': 'DRUG', 'otherNames': ['3-O-Caffeoylquinic, acid Heriguard'], 'description': 'Chologenic acid: 1200 mg per day for three months', 'armGroupLabels': ['Chlorogenic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Esperanza Martínez, PhD Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher Professor', 'investigatorFullName': 'Esperanza Martínez-Abundis', 'investigatorAffiliation': 'University of Guadalajara'}}}}