Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04133805
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2019-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Viscous Dietary Fibers on LDL-cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7845}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-16', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-Cholesterol', 'timeFrame': '≥ 3 weeks'}], 'secondaryOutcomes': [{'measure': 'non-HDL-Cholesterol', 'timeFrame': '≥ 3 weeks'}, {'measure': 'ApoB', 'timeFrame': '≥ 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['viscous fiber', 'barley b-glucan', 'oat b-glucan', 'konjac glucomannan', 'psyllium', 'guar gum', 'pectin'], 'conditions': ['Cardiovascular Risk Factor', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB.', 'detailedDescription': 'Medline, Embase, CINAHL, and the Cochrane Central databases were searched through May 13, 2019. Three independent reviews extracted data and assessed risk of bias. Randomized controlled trials that assessed the effect of barley b-glucan, oat b-glucan, konjac glucomannan (KJM), psyllium, guar gum, and pectin, with a study duration of ≥ 3 weeks, in adults with or without hypercholesterolemia were included. Data were pooled using the generic inverse variance method with random effects models and expressed as mean differences with 95% confidence intervals. Heterogeneity was assessed by the Cochran Q statistic and quantified by I2 statistic. Overall quality of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a randomized controlled clinical trial with either a parallel or cross-over design\n* have a treatment period of at least 3 weeks\n* Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes were all acceptable\n* Sources from β-glucan oats, β-glucan barley, konjac, psyllium, guar gum, and pectin were accepted\n* The amount of soluble fiber must be reported or measured or must be computable.\n* Must be appropriately controlled.\n* Must measure one of LDL-C, non-HDL-C or ApoB. These lipid measures can be either primary or secondary outcomes.\n* Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures\n\nExclusion Criteria:\n\n* If the study was insufficiently controlled, i.e. the control was another soluble fiber\n* If the soluble fiber was a combination supplement or in whole food sources where the amount of soluble fiber could not be isolated\n* If the outcome measures did not include LDL-C, non-HDL-C or ApoB\n* If the treatment period was less than 3 weeks\n* If the study was from a non-adult population\n* If the study provided insufficient information to calculate a magnitude of effect\n* Secondary information such as reviews, editorials, commentaries, were excluded\n* If the dose was less than 0.4g/day'}, 'identificationModule': {'nctId': 'NCT04133805', 'briefTitle': 'The Effect of Viscous Dietary Fibers on LDL-cholesterol', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'The Effect of Viscous Dietary Fibers on LDL-cholesterol: A Systematic Review and Meta-analysis of Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'Viscous fiber on LDL-C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'viscous fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': 'ex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Risk Factor and Modification Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}