Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02875392
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vw1017@gmail.com', 'phone': '+886229307930', 'title': 'Ming-Shun Wu', 'organization': 'Taipei Municipal Wanfang Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in ALT Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, {'id': 'OG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.'}], 'classes': [{'title': 'First Month', 'categories': [{'measurements': [{'value': '42.238', 'spread': '17.196', 'groupId': 'OG000'}, {'value': '33.524', 'spread': '21.736', 'groupId': 'OG001'}]}]}, {'title': 'Sixth Month', 'categories': [{'measurements': [{'value': '36.667', 'spread': '16.01', 'groupId': 'OG000'}, {'value': '36.238', 'spread': '22.221', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in AST Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, {'id': 'OG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.'}], 'classes': [{'title': 'First Month', 'categories': [{'measurements': [{'value': '28.095', 'spread': '7.049', 'groupId': 'OG000'}, {'value': '27.905', 'spread': '15.776', 'groupId': 'OG001'}]}]}, {'title': 'Sixth Month', 'categories': [{'measurements': [{'value': '25.286', 'spread': '7.349', 'groupId': 'OG000'}, {'value': '28.048', 'spread': '14.165', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, {'id': 'OG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.'}], 'classes': [{'title': 'First Month', 'categories': [{'measurements': [{'value': '5.871', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '6.057', 'spread': '0.451', 'groupId': 'OG001'}]}]}, {'title': 'Sixth Month', 'categories': [{'measurements': [{'value': '5.79', 'spread': '0.525', 'groupId': 'OG000'}, {'value': '6.152', 'spread': '0.608', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, {'id': 'FG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'The subjects did not inform their Hepatobiliary disorders; hence, their data did not analyze', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fucoidan Use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)\n\n275mg Oligo Fucoidan + 275mg HS Fucoxanthin: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, {'id': 'BG001', 'title': 'Placebo Pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)\n\nplacebo pills: taking placebo pills as if patients are under treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', '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': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', '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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-04', 'size': 334844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-18T03:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2016-08-05', 'resultsFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-23', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ALT Index', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.'}, {'measure': 'Change in AST Index', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation'}, {'measure': 'Change in HbA1c', 'timeFrame': '6 months', 'description': 'Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '33993853', 'type': 'DERIVED', 'citation': 'Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.'}]}, 'descriptionModule': {'briefSummary': 'Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.', 'detailedDescription': 'Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological activity. However, patients need to take actual fucoidan in order to reach the best effectiveness for inhibiting cancer cell.\n\nStudies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).\n\nExclusion Criteria:\n\n1. Patients were allergic to seafood.\n2. Patients who take Vitamin E or Pioglitazone.'}, 'identificationModule': {'nctId': 'NCT02875392', 'briefTitle': 'Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'N201605071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fucoidan use', 'description': 'FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)', 'interventionNames': ['Other: 275mg Oligo Fucoidan + 275mg HS Fucoxanthin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo pills', 'description': 'placebo capsule 6 per day (before breakfast and supper)', 'interventionNames': ['Other: placebo pills']}], 'interventions': [{'name': '275mg Oligo Fucoidan + 275mg HS Fucoxanthin', 'type': 'OTHER', 'description': 'Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.', 'armGroupLabels': ['Fucoidan use']}, {'name': 'placebo pills', 'type': 'OTHER', 'description': 'taking placebo pills as if patients are under treatment.', 'armGroupLabels': ['placebo pills']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'WanFangH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-Shung Wu, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wanfang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}