Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 4:18 AM
Study NCT ID:
NCT03118167
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2016-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020106', 'term': 'Acrylamide'}], 'ancestors': [{'id': 'D000178', 'term': 'Acrylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2017-04-14', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of four urinary biomarkers of acrylamide', 'timeFrame': 'up to 48 hours', 'description': 'Urine was collected prior to the potato chips meal and 48 hours thereafter, up to 10 urine samples for each participants. Urinary biomarkers of acrylamide were detected by UHPLC-MS/MS.'}, {'measure': 'Change of two hemoglobin adducts of acrylamide', 'timeFrame': 'baseline, 3 and 10 days', 'description': 'Blood samples were collected in 0, 3, 10days after the intake of potato chips meals. Two hemoglobin adducts (AAVal and GAVal) of acrylamide were detected by UHPLC-MS/MS.'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers', 'timeFrame': 'baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours', 'description': 'Dynamic changes of biomarkers during the specified intervention period, following 10 urine samples in 48 hours thereafter.'}, {'measure': 'Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers', 'timeFrame': '48 hours', 'description': 'Maximum concentration of urinary biomarkers during the specified period, measured by curve fitting tools of Matlab Software.'}, {'measure': 'Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers', 'timeFrame': '48 hours', 'description': 'Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers during the specified period, measured by curve fitting tools of Matlab Software.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acrylamide', 'Tea polyphenols', 'Water-soluble antioxidant of bamboo leaves'], 'conditions': ['Intervention']}, 'descriptionModule': {'briefSummary': 'A double-blind randomized controlled trial (RCT) was conducted in current human study. This study aims to investigate the intervention effect of AOB-w on the short-term exposure and toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing, in Chinese adolescents.', 'detailedDescription': 'In the morning of test day, participants were served with a meal of potato chips, corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study till entire study finished. Four mercapturic acid metabolites have been investigated as urinary biomarkers for short-term internal exposure of acrylamide in human'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has no smoking or drinking hobby\n\nExclusion Criteria:\n\n* Having any drugs within 7days\n* Smoking or drinking\n* Pregnant, trying to become pregnant or breast feeding\n* Allergic frying foods'}, 'identificationModule': {'nctId': 'NCT03118167', 'briefTitle': 'Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Intervention Effect of Tea Polyphenols (TP) and Water-Soluble Antioxidant Of Bamboo Leaves (AOB-w) on Short- and Long-term Internal Exposure of Acrylamide in Chinese Adolescents', 'orgStudyIdInfo': {'id': 'RCT-001-AA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tea polyphenols & Acrylamide', 'description': 'TP 0.05g, 0.1g, 0.2g (starches filled, up to 0.35g) capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose', 'interventionNames': ['Dietary Supplement: Tea polyphenols', 'Other: Acrylamide (Potato Chips)']}, {'type': 'EXPERIMENTAL', 'label': 'AOB-w & Acrylamide', 'description': 'AOB-w 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose', 'interventionNames': ['Dietary Supplement: AOB-w', 'Other: Acrylamide (Potato Chips)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo & Acrylamide', 'description': 'Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose', 'interventionNames': ['Other: Placebo', 'Other: Acrylamide (Potato Chips)']}], 'interventions': [{'name': 'Tea polyphenols', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['TP'], 'description': 'Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule', 'armGroupLabels': ['Tea polyphenols & Acrylamide']}, {'name': 'AOB-w', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Water-soluble antioxidant of bamboo leaves'], 'description': 'Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule', 'armGroupLabels': ['AOB-w & Acrylamide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Edible starches 0.35g, edible capsule', 'armGroupLabels': ['Placebo & Acrylamide']}, {'name': 'Acrylamide (Potato Chips)', 'type': 'OTHER', 'description': 'Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )', 'armGroupLabels': ['AOB-w & Acrylamide', 'Placebo & Acrylamide', 'Tea polyphenols & Acrylamide']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yu Zhang', 'investigatorAffiliation': 'Zhejiang University'}}}}