Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 1:55 PM
Study NCT ID:
NCT05773794
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssang@ncat.edu', 'phone': '7042505710', 'title': 'Dr. Shengmin Sang', 'organization': 'North Carolina A&T State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'N/A. We successfully enrolled 16 participants for each of the three proposed PK studies, with no dropouts during the trials.'}}, 'adverseEventsModule': {'timeFrame': '17 days for each intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Soymilk Consumption', 'description': 'Participants consumed 460 mL of soymilk in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo for Soymilk Consumption', 'description': 'Participants consumed 460 mL of 2% reduced fat milk in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Green Tea Consumption', 'description': 'Participants consumed 460 ml of green tea made from 2 servings (4 g) in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo for Green Tea Consumption', 'description': 'Participants consumed 460 ml of water in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Blueberry Consumption', 'description': 'Participants consumed 460 ml of blueberry powder (50 g) in water in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo for Blueberry Consumption', 'description': 'Participants consumed 460 ml of blueberry powder placebo (50 g) in water in a single dose.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 8 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Soymilk Consumption', 'description': 'Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of major RCS (MGO) and their major conjugates of polyphenols in human urine.'}, {'id': 'OG001', 'title': 'Placebo for Soymilk Consumption', 'description': 'Participants consumed 460 ml of 2% reduced fat milk in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine.'}, {'id': 'OG002', 'title': 'Green Tea Consumption', 'description': 'Participants consumed 460 ml of green tea from two serving bags in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine.'}, {'id': 'OG003', 'title': 'Placebo for Green Tea Consumption', 'description': 'Participants consumed 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine.'}, {'id': 'OG004', 'title': 'Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine.'}, {'id': 'OG005', 'title': 'Placebo for Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder placebo in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine.'}], 'classes': [{'title': 'MGO at 0-2 h', 'categories': [{'measurements': [{'value': '3.71', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '4.98', 'spread': '0.77', 'groupId': 'OG003'}, {'value': '7.38', 'spread': '2.93', 'groupId': 'OG004'}, {'value': '8.10', 'spread': '2.72', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 2-4 h', 'categories': [{'measurements': [{'value': '4.41', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '4.49', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '4.79', 'spread': '0.63', 'groupId': 'OG003'}, {'value': '7.66', 'spread': '2.64', 'groupId': 'OG004'}, {'value': '8.11', 'spread': '2.24', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 4-6 h', 'categories': [{'measurements': [{'value': '3.37', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '4.41', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '0.67', 'groupId': 'OG003'}, {'value': '5.82', 'spread': '1.94', 'groupId': 'OG004'}, {'value': '6.52', 'spread': '2.13', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 6-8 h', 'categories': [{'measurements': [{'value': '3.23', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '4.56', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '5.06', 'spread': '1.11', 'groupId': 'OG003'}, {'value': '4.77', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '4.53', 'spread': '1.17', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.366', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.05', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose', 'description': 'Major RCS in urine will be outlined using Liquid chromatography-tandem mass spectrometry (LC-MS). The urinary levels of major RCS over 8 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.', 'unitOfMeasure': 'nmol/mSmo', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Plasma Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 4 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Soymilk Consumption', 'description': 'Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}, {'id': 'OG001', 'title': 'Placebo for Soymilk Consumption', 'description': 'Participants consumed 460 ml of 2% reduced fat milk in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}, {'id': 'OG002', 'title': 'Green Tea Consumption', 'description': 'Participants consumed 460 ml of green tea from two serving bags (4 g). The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}, {'id': 'OG003', 'title': 'Placebo for Green Tea Consumption', 'description': 'Participants consumed 460 ml of water. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}, {'id': 'OG004', 'title': 'Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}, {'id': 'OG005', 'title': 'Placebo for Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder placebo in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) in human plasma.'}], 'classes': [{'title': 'MGO at 0 h', 'categories': [{'measurements': [{'value': '388.81', 'spread': '194.58', 'groupId': 'OG000'}, {'value': '414.10', 'spread': '211.59', 'groupId': 'OG001'}, {'value': '265.62', 'spread': '90.11', 'groupId': 'OG002'}, {'value': '266.84', 'spread': '58.88', 'groupId': 'OG003'}, {'value': '800.22', 'spread': '145.41', 'groupId': 'OG004'}, {'value': '783.50', 'spread': '151.67', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 0.5 h', 'categories': [{'measurements': [{'value': '349.00', 'spread': '202.39', 'groupId': 'OG000'}, {'value': '579.12', 'spread': '264.45', 'groupId': 'OG001'}, {'value': '235.66', 'spread': '99.01', 'groupId': 'OG002'}, {'value': '245.23', 'spread': '125.26', 'groupId': 'OG003'}, {'value': '680.86', 'spread': '241.39', 'groupId': 'OG004'}, {'value': '542.16', 'spread': '184.62', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 1.0 h', 'categories': [{'measurements': [{'value': '508.52', 'spread': '113.90', 'groupId': 'OG000'}, {'value': '652.50', 'spread': '182.36', 'groupId': 'OG001'}, {'value': '397.41', 'spread': '227.10', 'groupId': 'OG002'}, {'value': '434.22', 'spread': '197.90', 'groupId': 'OG003'}, {'value': '448.25', 'spread': '200.51', 'groupId': 'OG004'}, {'value': '488.45', 'spread': '323.42', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 1.5 h', 'categories': [{'measurements': [{'value': '281.63', 'spread': '99.55', 'groupId': 'OG000'}, {'value': '676.58', 'spread': '255.80', 'groupId': 'OG001'}, {'value': '288.82', 'spread': '124.72', 'groupId': 'OG002'}, {'value': '276.45', 'spread': '87.94', 'groupId': 'OG003'}, {'value': '179.23', 'spread': '60.95', 'groupId': 'OG004'}, {'value': '253.73', 'spread': '190.67', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 2.0 h', 'categories': [{'measurements': [{'value': '403.56', 'spread': '142.80', 'groupId': 'OG000'}, {'value': '531.82', 'spread': '176.33', 'groupId': 'OG001'}, {'value': '401.58', 'spread': '193.72', 'groupId': 'OG002'}, {'value': '414.64', 'spread': '194.55', 'groupId': 'OG003'}, {'value': '499.80', 'spread': '156.25', 'groupId': 'OG004'}, {'value': '478.71', 'spread': '152.22', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 3.0 h', 'categories': [{'measurements': [{'value': '253.72', 'spread': '317.69', 'groupId': 'OG000'}, {'value': '321.49', 'spread': '146.08', 'groupId': 'OG001'}, {'value': '326.86', 'spread': '165.36', 'groupId': 'OG002'}, {'value': '403.98', 'spread': '203.01', 'groupId': 'OG003'}, {'value': '307.07', 'spread': '56.13', 'groupId': 'OG004'}, {'value': '307.85', 'spread': '92.04', 'groupId': 'OG005'}]}]}, {'title': 'MGO at 4.0 h', 'categories': [{'measurements': [{'value': '252.68', 'spread': '117.25', 'groupId': 'OG000'}, {'value': '347.67', 'spread': '139.16', 'groupId': 'OG001'}, {'value': '322.85', 'spread': '130.64', 'groupId': 'OG002'}, {'value': '342.93', 'spread': '214.31', 'groupId': 'OG003'}, {'value': '522.59', 'spread': '126.55', 'groupId': 'OG004'}, {'value': '482.44', 'spread': '191.36', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.11', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose', 'description': 'Major RCS in plasma will be outlined using liquid chromatography-tandem mass spectrometry (LC-MS). The major RCS levels in plasma over 4 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Soymilk Consumption', 'description': 'Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}, {'id': 'OG001', 'title': 'Placebo for Soymilk Consumption', 'description': 'Participants consumed 460 ml of 2% reduced fat milk in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}, {'id': 'OG002', 'title': 'Green Tea Consumption', 'description': 'Participants consumed 460 ml of green tea from two serving bags in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}, {'id': 'OG003', 'title': 'Placebo for Green Tea Consumption', 'description': 'Participants consumed 460 ml of water in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}, {'id': 'OG004', 'title': 'Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder in 460 ml water in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}, {'id': 'OG005', 'title': 'Placebo for Blueberry Consumption', 'description': 'Participants consumed 50 g of blueberry powder placebo in 460 ml water in a single dose. The analysis is to assess the levels of major RCS conjugates of polyphenols in human urine.'}], 'classes': [{'title': 'MGO-EC at 0-2 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.019', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}, {'title': 'MGO-EC at 2-4 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.048', 'spread': '0.021', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}, {'title': 'MGO-EC at 4-6 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.033', 'spread': '0.013', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}, {'title': 'MGO-EC at 6-8 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.018', 'spread': '0.008', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}, {'title': 'MGO-EC at 8-12 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.011', 'spread': '0.008', 'groupId': 'OG002'}, {'value': '0.0012', 'spread': '0.003', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}, {'title': 'MGO-EC at 12-24 h', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG001'}, {'value': '0.0027', 'spread': '0.005', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is below the lower limit of detection and unable to be quantified.', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0196', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.05', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose', 'description': 'Major RCS conjugates of polyphenols in urine after soymilk, green tea, or blueberry consumption will be profiled using liquid chromatography-tandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk, green tea, or blueberry consumption will be quantified using LC-MS.', 'unitOfMeasure': 'nmol/mSmo', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'timeFrame': '0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 24 hours pose dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in plasma over 24 hours after one single dose of soymilk, green tea, or blueberry consumption.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'Change in Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols in Feces Over 48 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'timeFrame': '0 hour, 24 hours, and 48 hours post-dose', 'description': 'Major RCS adducts in fecal samples after soymilk, green tea, or blueberry consumption will be profiled. Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in fecal samples.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Soymilk Consumption First, Then Placebo', 'description': 'Eight participants consumed 460 mL of soymilk in a single dose on the first intervention and 460 ml of 2% reduced fat milk in a single dose on the second intervention'}, {'id': 'FG001', 'title': 'Placebo First, Then Soymilk Consumption', 'description': 'Eight participants consumed 460 ml of 2% reduced fat milk in a single dose on the first intervention and 460 ml of soymilk in a single dose on the second intervention'}, {'id': 'FG002', 'title': 'Green Tea Consumption First, Then Placebo', 'description': 'Seven participants consumed 460 mL of green tea made from 2 servings (4 g) in a single dose on the first intervention and 460 ml water in a single dose on the second intervention'}, {'id': 'FG003', 'title': 'Placebo First, Then Green Tea Consumption', 'description': 'Nine participants consumed 460 ml water in a single dose on the first intervention and 460 mL of green tea made from 2 servings (4 g) in a single dose on the second intervention'}, {'id': 'FG004', 'title': 'Blueberry Consumption First, Then Placebo', 'description': 'Eight participants consumed 460 mL of blueberry powder (50 g) in water in a single dose on the first intervention and 460 ml blueberry powder placebo (50 g) in water in a single dose on the second intervention'}, {'id': 'FG005', 'title': 'Placebo First, Then Blueberry Consumption', 'description': 'Eight participants consumed 460 mL of blueberry powder placebo (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder (50 g) in water in a single dose on the second intervention'}], 'periods': [{'title': 'Wash-in Period (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Wash-out Period (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All participants were asked to avoid the consumption of any soymilk, green tea, and blueberry products one week before the study and continuing throughout the entire study except of the intervention days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Soymilk Consumption First, Then Placebo', 'description': 'Eight participants consumed 460 mL of soymilk in a single dose on the first intervention and 460 mL of 2% reduced fat milk in a single dose on the second intervention'}, {'id': 'BG001', 'title': 'Placebo First, Then Soymilk Consumption', 'description': 'Eight participants consumed 460 mL of 2% reduced fat milk in a single dose on the first intervention and 460 mL of soymilk in a single dose on the second intervention'}, {'id': 'BG002', 'title': 'Green Tea Consumption First, Then Placebo', 'description': 'Seven participants consumed 460 mL of green tea made from two servings (4 g) in a single dose on the first intervention and 460 mL of water in a single dose on the second intervention'}, {'id': 'BG003', 'title': 'Placebo First, Then Green Tea Consumption', 'description': 'Nine participants consumed 460 mL of water in a single dose on the first intervention and 460 mL of green tea made from two servings (4 g) in a single dose on the second intervention'}, {'id': 'BG004', 'title': 'Blueberry Consumption First, Then Placebo', 'description': 'Eight participants consumed 460 mL of blueberry powder (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder placebo (50 g) in water in a single dose on the second intervention'}, {'id': 'BG005', 'title': 'Placebo First, Then Blueberry Consumption', 'description': 'Eight participants consumed 460 mL of blueberry powder placebo (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder (50 g) in water in a single dose on the second intervention'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '65'}, {'value': '38.625', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '62'}, {'value': '47.857', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '59'}, {'value': '40.11', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '65'}, {'value': '41.375', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '65'}, {'value': '44.375', 'groupId': 'BG005', 'lowerLimit': '25', 'upperLimit': '65'}, {'value': '41.0625', 'groupId': 'BG006', 'lowerLimit': '21', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.89', 'groupId': 'BG000', 'lowerLimit': '20.3', 'upperLimit': '27.8'}, {'value': '26.76', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '33'}, {'value': '25.21', 'groupId': 'BG002', 'lowerLimit': '18.5', 'upperLimit': '36.9'}, {'value': '23.94', 'groupId': 'BG003', 'lowerLimit': '19.6', 'upperLimit': '27.5'}, {'value': '23.89', 'groupId': 'BG004', 'lowerLimit': '20.56', 'upperLimit': '34.39'}, {'value': '25.25', 'groupId': 'BG005', 'lowerLimit': '20.87', 'upperLimit': '28.44'}, {'value': '25', 'groupId': 'BG006', 'lowerLimit': '18.5', 'upperLimit': '36.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 791111, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-03T18:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-02-23', 'resultsFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-08', 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 8 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.', 'timeFrame': 'assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose', 'description': 'Major RCS in urine will be outlined using Liquid chromatography-tandem mass spectrometry (LC-MS). The urinary levels of major RCS over 8 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.'}, {'measure': 'Change in Plasma Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 4 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.', 'timeFrame': 'assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose', 'description': 'Major RCS in plasma will be outlined using liquid chromatography-tandem mass spectrometry (LC-MS). The major RCS levels in plasma over 4 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.'}, {'measure': 'Change in Urinary Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'timeFrame': '0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose', 'description': 'Major RCS conjugates of polyphenols in urine after soymilk, green tea, or blueberry consumption will be profiled using liquid chromatography-tandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk, green tea, or blueberry consumption will be quantified using LC-MS.'}], 'secondaryOutcomes': [{'measure': 'Change in Plasma Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'timeFrame': '0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 24 hours pose dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in plasma over 24 hours after one single dose of soymilk, green tea, or blueberry consumption.'}, {'measure': 'Change in Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols in Feces Over 48 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.', 'timeFrame': '0 hour, 24 hours, and 48 hours post-dose', 'description': 'Major RCS adducts in fecal samples after soymilk, green tea, or blueberry consumption will be profiled. Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in fecal samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dietary flavonoids', 'Pharmacokinetics', 'Reactive Carbonyl Species', 'Polyphenols'], 'conditions': ['Human Health', 'Reactive Carbonyl Species', 'Polyphenols']}, 'descriptionModule': {'briefSummary': 'This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of dietary polyphenols (soymilk, green tea, and blueberry) in humans after a single dose of dietary flavonoids.', 'detailedDescription': 'A crossover design was used. Sixteen healthy volunteers (16 for each study, in total 48) were recruited and asked to avoid the consumption of any soymilk, green tea, and blueberry products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.\n\nOn week 2, each of the eight participants received 460 ml of soymilk, green tea, and blueberry in a single dose, and afterward, urine and blood samples at different time points over 24 h and fecal samples at different time points over 48 h were collected. Meanwhile, the other eight participants received breakfast (without any soymilk, green tea, and blueberry) at different time points over 48 h were collected.\n\nOn the contrary, on week 3, eight participants who received regular milk or water on week 2 received breakfast only, and eight participants who were used as a control on week 2 received soymilk, green tea, and blueberry. And urine and blood samples at different time points over 24 h, and fecal samples at different time points over 48 h for both groups were collected.\n\nSamples will be analyzed by LC-MS/MS. The Pharmacokinetics of conjugates will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 25-70 years\n2. BMI between 18 and 30\n3. Have no known allergy to soy milk\n4. Be not taking antibiotics for six months\n5. Be not currently taking medication\n\n 1. No taking any prescription drugs\n 2. If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided.\n\n Major brands Notes: All flavonoid-enriched supplements should be avoided. Soy Isoflavones/ tea/blueberry Lipo-Flavonoid Citrus Bioflavonoids Complex Super Flavonoids Super Antioxidants Quercetin Supplement Essential-C and flavonoids Milk Thistle Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc\n 3. No any drugs or supplements within three weeks of the experiment\n6. Be nonsmoking\n7. Have no alcoholic intoxication\n\n 1. No alcoholic addiction\n 2. \\< 3-4 drinks per week (less than 2 glasses (300 mL) per drink)\n 3. No alcohol within 3 three weeks of the experiment\n8. Have no extended exposure to industrial wastes\n\nExclusion Criteria:\n\n1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders\n2. Cancer patients\n\n 1. Currently diagnosed cancer patients will be excluded;\n 2. Medication free for \\>2 years could be considered;'}, 'identificationModule': {'nctId': 'NCT05773794', 'briefTitle': 'Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans', 'organization': {'class': 'OTHER', 'fullName': 'North Carolina Agriculture & Technical State University'}, 'officialTitle': 'Scavenging of Reactive Carbonyl Species by Dietary Flavonoids From Soymilk, Green Tea, and Blueberry in Humans', 'orgStudyIdInfo': {'id': '22-0093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary flavonoids (soymilk) consumption', 'description': 'Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.\n\nWeek 2: Participants consumed a breakfast including 460 mL of soymilk (or milk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.\n\nWeek 3: Participants consumed a breakfast including 460 mL of milk (or soymilk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.', 'interventionNames': ['Dietary Supplement: Soymilk, green tea, or blueberry', 'Dietary Supplement: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary flavonoids (blueberry) consumption', 'description': 'Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.\n\nWeek 2: Participants consumed a breakfast including 460 mL of blueberry water (or placebo sweet water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.\n\nWeek 3: Participants consumed a breakfast including 460 mL of placebo sweet water (or blueberry water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.', 'interventionNames': ['Dietary Supplement: Soymilk, green tea, or blueberry', 'Dietary Supplement: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary flavonoids (green tea) consumption', 'description': 'Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.\n\nWeek 2: Participants consumed a breakfast including 460 mL of green tea (or water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.\n\nWeek 3: Participants consumed a breakfast including 460 mL of water (or green tea) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.', 'interventionNames': ['Dietary Supplement: Soymilk, green tea, or blueberry', 'Dietary Supplement: Control group']}], 'interventions': [{'name': 'Soymilk, green tea, or blueberry', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.', 'armGroupLabels': ['Dietary flavonoids (blueberry) consumption', 'Dietary flavonoids (green tea) consumption', 'Dietary flavonoids (soymilk) consumption']}, {'name': 'Control group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast with milk or water, without soymilk, green tea, or blueberry blends.', 'armGroupLabels': ['Dietary flavonoids (blueberry) consumption', 'Dietary flavonoids (green tea) consumption', 'Dietary flavonoids (soymilk) consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Agriculture and Technical State University', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}], 'overallOfficials': [{'name': 'Shengmin Sang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NC A&T State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Carolina Agriculture & Technical State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Shengmin Sang', 'investigatorAffiliation': 'North Carolina Agriculture & Technical State University'}}}}