Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-30 @ 8:12 AM
Study NCT ID:
NCT00951912
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2009-08-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004742', 'term': 'daidzein'}, {'id': 'D019833', 'term': 'Genistein'}], 'ancestors': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yanbinye72@163.com', 'phone': '8620-87755766', 'title': 'Dr. Yan-bin Ye', 'phoneExt': '8179', 'organization': 'the First Affiliated Hospital of Sun Yat-sen University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A relative long time of recruitment leading to a little different in dietary intakes among subjects;The menstrual period will leading to different estradiol;The different severity of the diabetes leading to the different dropout percentage.'}}, 'adverseEventsModule': {'timeFrame': 'We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'the placebo group were given 10g soy protein isolated without isoflavones', 'otherNumAtRisk': 54, 'otherNumAffected': 4, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Daidzein', 'description': 'Daidzein group were given 10g soy protein isolated and 50mg purify daidzein', 'otherNumAtRisk': 55, 'otherNumAffected': 4, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Genistein', 'description': 'Genistein group were given 10g soy protein isolated and 50mg purify genistein', 'otherNumAtRisk': 56, 'otherNumAffected': 2, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vignal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperplasia of mammary glands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'thirsty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.80', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '12.61', 'groupId': 'OG001'}, {'value': '-4.89', 'spread': '11.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7981', 'ciLowerLimit': '-6.6569', 'ciUpperLimit': '5.0607', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.422', 'groupDescription': 'Null hypothesis: There are no difference in the difference of changes in plasma glucose.\n\nPower calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0842', 'ciLowerLimit': '-2.7486', 'ciUpperLimit': '8.9171', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.411', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8823', 'ciLowerLimit': '-1.9234', 'ciUpperLimit': '9.6881', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.399', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'the number of participants for analysis was determined by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in 120-minutes Postload Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.90', 'spread': '20.67', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '20.60', 'groupId': 'OG001'}, {'value': '-5.59', 'spread': '24.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7696', 'ciLowerLimit': '-11.9308', 'ciUpperLimit': '8.3916', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.2000', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6929', 'ciLowerLimit': '-9.4232', 'ciUpperLimit': '10.8091', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.1818', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4626', 'ciLowerLimit': '-7.6067', 'ciUpperLimit': '12.5318', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.1624', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline\\*100%', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in HbA1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.38', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '5.99', 'groupId': 'OG001'}, {'value': '-1.30', 'spread': '9.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01174', 'ciLowerLimit': '-3.5428', 'ciUpperLimit': '3.5194', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45967', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.68659', 'ciLowerLimit': '-6.2020', 'ciUpperLimit': '0.8288', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45320', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.67485', 'ciLowerLimit': '-6.174', 'ciUpperLimit': '0.8243', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44646', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed was determinted by intention to treat.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in AUC of Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.23', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '16.98', 'groupId': 'OG001'}, {'value': '-5.24', 'spread': '17.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9661', 'ciLowerLimit': '-10.5857', 'ciUpperLimit': '4.6535', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14977', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9972', 'ciLowerLimit': '-8.5830', 'ciUpperLimit': '6.5886', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.13581', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9689', 'ciLowerLimit': '-5.5817', 'ciUpperLimit': '9.5195', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.12126', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patticipants was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Fasting Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '25.27', 'spread': '114.23', 'groupId': 'OG000'}, {'value': '21.41', 'spread': '91.23', 'groupId': 'OG001'}, {'value': '6.06', 'spread': '78.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Rank', 'paramValue': '1.442', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '22.83', 'spread': '107.41', 'groupId': 'OG000'}, {'value': '21.60', 'spread': '98.88', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '64.03', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Ranks', 'paramValue': '1.895', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in QUICKI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.32', 'spread': '19.47', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '15.60', 'groupId': 'OG001'}, {'value': '6.29', 'spread': '17.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Ranks', 'paramValue': '2.169', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.\n\nThe percentage change was caculated as (6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '40.06', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '11.90', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '15.83', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4370', 'ciLowerLimit': '-8.444', 'ciUpperLimit': '15.318', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9113', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4809', 'ciLowerLimit': '-8.3475', 'ciUpperLimit': '15.3092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8896', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0439', 'ciLowerLimit': '-11.7296', 'ciUpperLimit': '11.8174', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8669', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Triglyceride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.93', 'spread': '45.50', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '38.90', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '39.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean ranks', 'paramValue': '1.031', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was determinted by intention to treat'}, {'type': 'PRIMARY', 'title': 'Percentage Change in High Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '20.40', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '15.21', 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[{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'All participants were received 10g soy protein isolated without isoflavones daily'}, {'id': 'OG001', 'title': 'Daidzein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify daidzein daily'}, {'id': 'OG002', 'title': 'Geinstein Group', 'description': 'All participants were received 10g soy protein isolated plus 50mg purify genistein daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '6.54', 'spread': '8.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.1557', 'ciLowerLimit': 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'description': 'the placebo group were given 10g soy protein isolated without isoflavones'}, {'id': 'FG001', 'title': 'Daidzein', 'description': 'Daidzein group were given 10g soy protein isolated and 50mg purify daidzein'}, {'id': 'FG002', 'title': 'Genistein', 'description': 'Genistein group were given 10g soy protein isolated and 50mg purify genistein'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 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'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other: Stroke', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'the recruitment period last about half a year,and the types of location are clinic of endocrinology and nutritional clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'the placebo group were given 10g soy protein isolated without isoflavones'}, {'id': 'BG001', 'title': 'Daidzein', 'description': 'Daidzein group were given 10g soy protein isolated and 50mg purify daidzein'}, {'id': 'BG002', 'title': 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'resultsFirstSubmitQcDate': '2012-09-15', 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Fasting Plasma Glucose', 'timeFrame': 'Baseline,6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in 120-minutes Postload Plasma Glucose', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline\\*100%'}, {'measure': 'Percentage Change in HbA1C', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in AUC of Glucose', 'timeFrame': 'Baseline, 6 months', 'description': 'values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in Fasting Plasma Insulin', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in HOMA-IR', 'timeFrame': 'Baseline, 6 months', 'description': 'HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in QUICKI', 'timeFrame': 'Baseline, 6 months', 'description': 'QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.\n\nThe percentage change was caculated as (6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in Total Cholesterol', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in Triglyceride', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in High Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}, {'measure': 'Percentage Change in Low Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline, 6 months', 'description': '(6th month value-baseline value)/baseline value\\*100%'}], 'secondaryOutcomes': [{'measure': 'Total Urinary Isoflavones', 'timeFrame': '3 months'}, {'measure': 'Urinary Daidzein', 'timeFrame': '3 months', 'description': 'Urinary daidzein excretion'}, {'measure': 'Urinary Genistein', 'timeFrame': '3 months', 'description': 'Urinary genistein excretion'}, {'measure': 'Total Energy Intake at Follow-up', 'timeFrame': 'an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.', 'description': 'The energy intake was evaluated by 3 days dietary records.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['genistein', 'daidzein', 'impaired glucose regulation', 'glucose metabolism', 'lipids metabolism', 'inflammation', 'women'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.', 'detailedDescription': "Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese women aged 30-70 y\n* Fasting glucose \\>=5.6 mmol/l; post-load glucose \\>=7.8 mmol/l\n\nExclusion Criteria:\n\n* Diabetes renal diseases\n* Confirmed CVD, chronic liver,kidney diseases,Thyroid disease\n* Medications affecting glucose or lipid metabolism'}, 'identificationModule': {'nctId': 'NCT00951912', 'briefTitle': 'The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation', 'orgStudyIdInfo': {'id': 'yanbinye'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10g soy protein isolated powder patch by mouth everyday for 6months', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Daidzein', 'description': '10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months', 'interventionNames': ['Dietary Supplement: Daidzein']}, {'type': 'EXPERIMENTAL', 'label': 'Genistein', 'description': '10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months', 'interventionNames': ['Dietary Supplement: Genistein']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g soy protein isolated per day', 'armGroupLabels': ['Placebo']}, {'name': 'Daidzein', 'type': 'DIETARY_SUPPLEMENT', 'description': '50mg daidzein +10g soy protein isolated per day', 'armGroupLabels': ['Daidzein']}, {'name': 'Genistein', 'type': 'DIETARY_SUPPLEMENT', 'description': '50mg genistein +10g soy protein isolated per day', 'armGroupLabels': ['Genistein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yan-bin Ye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Yu-ming Chen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Nutrition Society', 'class': 'UNKNOWN'}, {'name': 'Danone Institute International', 'class': 'OTHER'}, {'name': 'Department of Health of Guangdong Province', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'yanbinye', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}