Viewing Study NCT01857258


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Study NCT ID: NCT01857258
Status: COMPLETED
Last Update Posted: 2017-02-16
First Post: 2013-05-16
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bruno.27@osu.edu', 'phone': '6142925522', 'title': 'Richard Bruno, PhD, RD', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was limited to normoglycemic adults who were healthy. Future studies may consider populations having glucose intolerance to examine the extent to which green tea attenuates starch-induced hyperglycemia.'}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for any adverse events in response to ingesting starch-based confections containing no green tea or with green tea through study completion (9 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Green Tea, Then Control', 'description': 'Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control, Then Green Tea', 'description': 'Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve of Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '998', 'spread': '29', 'groupId': 'OG000'}, {'value': '981', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose', 'description': 'Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.', 'unitOfMeasure': 'mmol/L * min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve of Brachial Artery Flow Mediated Dilatiion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '614', 'spread': '65', 'groupId': 'OG000'}, {'value': '653', 'spread': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose', 'description': 'Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.', 'unitOfMeasure': '%FMD * min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brachial Artery Flow-mediated Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '3.71', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 min (baseline)', 'unitOfMeasure': '% dilation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brachial Artery Flow-mediated Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '3.23', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 min', 'unitOfMeasure': '% dilation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Malondialdehyde (0 Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 min)', 'unitOfMeasure': 'uM', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Malondialdehyde', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 min postprandially', 'unitOfMeasure': 'uM', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ratio of Asymmetric Dimethylarginine Relative to Arginine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '6.24', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 min (baseline)', 'unitOfMeasure': 'nmol/umol', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ratio of Asymmetric Dimethylarginine Relative to Arginine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}, {'id': 'OG001', 'title': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate\n\nGreen Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose'}], 'classes': [{'categories': [{'measurements': [{'value': '6.96', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 min (baseline)', 'unitOfMeasure': 'nmol/umol', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Green Tea First, Then Control', 'description': 'Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.\n\nThe green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate.'}, {'id': 'FG001', 'title': 'Control First, Then Green Tea', 'description': 'Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.\n\nThe green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate.'}], 'periods': [{'title': 'First Intervention (3 h Postprandially)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash-out Period (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (3 h Postprandially)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Baseline Participant Characteristics', 'description': 'All participants completed both arms of the cross-over study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '1.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '160.5', 'spread': '21.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2013-05-16', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-14', 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve of Blood Glucose', 'timeFrame': 'Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose', 'description': 'Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.'}, {'measure': 'Area Under the Curve of Brachial Artery Flow Mediated Dilatiion', 'timeFrame': 'Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose', 'description': 'Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.'}, {'measure': 'Brachial Artery Flow-mediated Dilation', 'timeFrame': '0 min (baseline)'}, {'measure': 'Brachial Artery Flow-mediated Dilation', 'timeFrame': '60 min'}], 'secondaryOutcomes': [{'measure': 'Malondialdehyde (0 Min)', 'timeFrame': 'Baseline (0 min)'}, {'measure': 'Malondialdehyde', 'timeFrame': '60 min postprandially'}, {'measure': 'Ratio of Asymmetric Dimethylarginine Relative to Arginine', 'timeFrame': '0 min (baseline)'}, {'measure': 'Ratio of Asymmetric Dimethylarginine Relative to Arginine', 'timeFrame': '60 min (baseline)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['green tea', 'catechins', 'vascular endothelial function', 'postprandial hyperglycemia', 'oxidative stress'], 'conditions': ['Hyperglycemia', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '27494176', 'type': 'RESULT', 'citation': 'Sapper TN, Mah E, Ahn-Jarvis J, McDonald JD, Chitchumroonchokchai C, Reverri EJ, Vodovotz Y, Bruno RS. A green tea-containing starch confection increases plasma catechins without protecting against postprandial impairments in vascular function in normoglycemic adults. Food Funct. 2016 Sep 14;7(9):3843-53. doi: 10.1039/c6fo00639f. Epub 2016 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by developing a green tea-containing confection, examining its physiochemical properties and its inhibition of starch digestion, and then validating its vasoprotective activities in healthy humans by assessing its blood glucose-regulating activities.', 'detailedDescription': 'The study involves validating a green tea confection (i.e. "gummy" candy) as a dietary strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by providing research participants 75 grams of carbohydrate in the form of a confection that contains no green tea concentrate or green tea concentrate at a level equivalent to approximately 3 cups of freshly brewed tea. Blood glucose and brachial artery flow-mediated dilation will be assessed at regular intervals during the 3 hour postprandial period to define the extent to which green tea attenuates postprandial increases in blood glucose and decreases in vascular function that otherwise occur in a hyperglycemia-dependent manner.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plasma glucose \\<100 mg/dL\n* Plasma total cholesterol \\<200 mg/dL\n* Plasma triglycerides \\<140 mg/dL\n* Blood pressure \\<140/90\n* non-dietary supplement user for \\>2 months\n* no use of medications known to affect carbohydrate metabolism,\n* nonsmoker / never smoker\n* no history of cardiovascular disease or gastrointestinal disorders\n\nExclusion Criteria:\n\n* allergies or aversions to green tea and/or corn starch,\n* excessive alcohol consumption (\\>3 drinks/d),\n* \\>5 h/wk of aerobic activity'}, 'identificationModule': {'nctId': 'NCT01857258', 'briefTitle': 'Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction', 'orgStudyIdInfo': {'id': '2013H0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Green Tea', 'description': 'Participants will be provided a confection containing green tea concentrate', 'interventionNames': ['Dietary Supplement: Green Tea Concentrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will be provided a confection devoid of green tea concentrate', 'interventionNames': ['Dietary Supplement: Green Tea Concentrate']}], 'interventions': [{'name': 'Green Tea Concentrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose', 'armGroupLabels': ['Control', 'Green Tea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Richard Bruno, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Richard Bruno', 'investigatorAffiliation': 'Ohio State University'}}}}