Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT03654651
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2018-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peanuts and Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pmk3@psu.edu', 'phone': '814-863-2923', 'title': 'Dr. Penny Kris-Etherton', 'organization': 'The Pennsylvania State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All 16-wks of trial', 'description': 'No subjects were at risk for serious adverse event or all-cause mortality. Therefore, these were not monitored. Adverse-events (e.g., allergic reactions to study foods) were monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-fat Higher-carbohydrate Snack', 'description': 'Evening lower-fat higher-carbohydrate snack'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '0.9'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '1.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '0.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fructosamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-5.1', 'upperLimit': '5.4'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-5.1', 'upperLimit': '5.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '3.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '5.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '5.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'umol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '1.0'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '0.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'umol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peripheral Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'title': 'Peripheral systolic within-condition mean difference', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '3.3'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '2.6'}]}]}, {'title': 'Peripheral diastolic within-condition mean difference', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '2.5'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '4.6', 'groupDescription': 'peripheral systolic BP', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.9', 'groupDescription': 'peripheral diastolic BP', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '3.3', 'groupDescription': 'peripheral systolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '2.6', 'groupDescription': 'peripheral systolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.5', 'groupDescription': 'peripheral diastolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'peripheral diastolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Central Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'title': 'Central systolic within-condition mean difference', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '3.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '2.1'}]}]}, {'title': 'Central diastolic within-condition mean difference', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '2.6'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '1.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '4.4', 'groupDescription': 'central systolic BP', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.3', 'groupDescription': 'central diastolic BP', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '3.1', 'groupDescription': 'central systolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '2.1', 'groupDescription': 'central systolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.6', 'groupDescription': 'central diastolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '1.6', 'groupDescription': 'central diastolic BP change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Carotid Femoral Pulse Wave Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery.\n\nWithin-condition mean differences (change from baseline).', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Augmentation Index (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '2.9'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '4.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '3.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '2.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '4.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness\n\nWithin-condition mean differences (change from baseline).', 'unitOfMeasure': '% adjusted to a HR of 75 BPM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '6.9'}, {'value': '-2.3', 'groupId': 'OG001', 'lowerLimit': '-6.8', 'upperLimit': '2.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '9.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '6.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '2.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.8'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '2.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '5.1'}, {'value': '-2.7', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '2.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '8.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '5.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '-17', 'groupId': 'OG000', 'lowerLimit': '-29.1', 'upperLimit': '-4.8'}, {'value': '-5.7', 'groupId': 'OG001', 'lowerLimit': '-17.1', 'upperLimit': '5.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-18.3', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17', 'ciLowerLimit': '-29.1', 'ciUpperLimit': '-4.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '5.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'change from baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Microbiota Alpha-diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Peanut Consumption', 'description': 'Evening Peanut Consumption'}, {'id': 'OG001', 'title': 'Evening Lower-Fat Higher-Carbohydrate Snack', 'description': 'Evening Lower-Fat Higher-Carbohydrate Snack'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '13.3'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '13.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': "Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established.\n\nPresented as endpoint mean values with IQR", 'unitOfMeasure': "Faith's Phylogenetic Diversity Score", 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Evening Peanut Consumption - Evening Snack Sequence', 'description': 'First intervention:\n\nParticipants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).\n\nPeanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.\n\nSecond intervention:\n\nParticipants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).\n\nHigh carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).'}, {'id': 'FG001', 'title': 'Evening Snack-Evening Peanut Consumption Sequence', 'description': 'First intervention:\n\nParticipants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).\n\nHigh carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).\n\nSecond intervention:\n\nParticipants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).\n\nPeanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (2-weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '267 participants were screened for eligibility', 'preAssignmentDetails': '51 participants were randomized. One participant withdrew from study before receiving either intervention'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Evening Peanut Consumption-Evening Snack Sequence', 'description': 'First intervention:\n\nParticipants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).\n\nPeanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.\n\nSecond Intervention:\n\nParticipants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).\n\nHigh carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).'}, {'id': 'BG001', 'title': 'Evening Snack-Evening Peanut Consumption Sequence', 'description': 'First Intervention:\n\nParticipants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).\n\nHigh carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).\n\nSecond Intervention:\n\nParticipants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).\n\nPeanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'spread': '15', 'groupId': 'BG000'}, {'value': '43', 'spread': '15', 'groupId': 'BG001'}, {'value': '42', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-04', 'size': 1066212, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-20T15:08', 'hasProtocol': True}, {'date': '2018-09-28', 'size': 167723, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-20T13:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2018-08-29', 'resultsFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-19', 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Glucose', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}], 'secondaryOutcomes': [{'measure': 'Fructosamine', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Fasting Insulin', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Peripheral Systolic and Diastolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Central Systolic and Diastolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Carotid Femoral Pulse Wave Velocity', 'timeFrame': '6 weeks', 'description': 'Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery.\n\nWithin-condition mean differences (change from baseline).'}, {'measure': 'Augmentation Index (%)', 'timeFrame': '6 weeks', 'description': 'A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness\n\nWithin-condition mean differences (change from baseline).'}, {'measure': 'LDL Cholesterol', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'HDL Cholesterol', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Total Cholesterol', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Triglycerides', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Body Weight', 'timeFrame': '6 weeks', 'description': 'Within-condition mean differences (change from baseline).'}, {'measure': 'Microbiota Alpha-diversity', 'timeFrame': '6 weeks', 'description': "Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established.\n\nPresented as endpoint mean values with IQR"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '34562081', 'type': 'DERIVED', 'citation': 'Sapp PA, Kris-Etherton PM, Petersen KS. Peanuts or an Isocaloric Lower Fat, Higher Carbohydrate Nighttime Snack Have Similar Effects on Fasting Glucose in Adults with Elevated Fasting Glucose Concentrations: a 6-Week Randomized Crossover Trial. J Nutr. 2022 Jan 11;152(1):153-162. doi: 10.1093/jn/nxab347.'}]}, 'descriptionModule': {'briefSummary': 'A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.', 'detailedDescription': 'A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking\n* Impaired fasting glucose at screening (≥ 100 mg/dL).\n* BMI ≥20 and ≤40 kg/m2.\n\nExclusion Criteria:\n\n* Diagnosed diabetes or fasting glucose \\>126 mg/dl\n* Systolic blood pressure \\>160mmHg or diastolic blood pressure \\>100mmHg)\n* Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs\n* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions\n* Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study\n* Pregnancy or lactation\n* Weight loss of \\>=10% of body weight within the 6 months prior to enrolling in the study\n* Smoking or use of any tobacco products\n* Allergy to test foods\n* Consumption of \\>14 alcoholic drinks/week'}, 'identificationModule': {'nctId': 'NCT03654651', 'briefTitle': 'Peanuts and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption', 'orgStudyIdInfo': {'id': 'use PKE_PEANUT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evening Peanut Consumption', 'description': 'Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).', 'interventionNames': ['Drug: Peanut']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Evening Snack', 'description': 'Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).', 'interventionNames': ['Drug: High carbohydrate snack']}], 'interventions': [{'name': 'Peanut', 'type': 'DRUG', 'description': 'Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.', 'armGroupLabels': ['Evening Peanut Consumption']}, {'name': 'High carbohydrate snack', 'type': 'DRUG', 'description': 'Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).', 'armGroupLabels': ['Evening Snack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Penny M Kris-Etherton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}, {'name': 'Kristina S Petersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Peanut Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}