Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02670967
Status:
UNKNOWN
Last Update Posted:
2016-02-02
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': '4 weeks'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '29153856', 'type': 'DERIVED', 'citation': 'Khan K, Jovanovski E, Ho HVT, Marques ACR, Zurbau A, Mejia SB, Sievenpiper JL, Vuksan V. The effect of viscous soluble fiber on blood pressure: A systematic review and meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2018 Jan;28(1):3-13. doi: 10.1016/j.numecd.2017.09.007. Epub 2017 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The present study conducted a meta-analysis of 22 randomly controlled trials to assess the effects of soluble fiber intake on blood pressure in human subjects.\n\nUsing the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and meta-analysis was conducted. Information regarding study methods, characteristics, mean BP and standard deviations were extracted The data from each study were pooled using a random effects model to estimate the effects of soluble fiber consumption on blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, hypertensive, hypercholesterolaemic, diabetic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Randomized Controlled Trials\n* Parallel or Crossover Design\n* Duration: \\>3 weeks\n* Human trials\n* Viscous (soluble) fiber\n* Viable endpoint data\n* Articles published in English\n\nExclusion Criteria:\n\n* Non-human\n* Non-randomized\n* Lack of control\n* Less than 4 weeks in duration\n* No viable endpoint data'}, 'identificationModule': {'nctId': 'NCT02670967', 'briefTitle': 'Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials', 'orgStudyIdInfo': {'id': 'FIberBPMeta'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Soluble Fibre', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vladimir Vuksan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'Kashif Khan, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}