Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-05 @ 5:18 PM
Study NCT ID:
NCT06127732
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phytosterol Supplementation and Lipoprotein Subfractions
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total and LDL-cholesterol', 'timeFrame': '12 weeks', 'description': 'Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol'}], 'secondaryOutcomes': [{'measure': 'Change in LDL subfractions', 'timeFrame': '12 weeks', 'description': 'Phytosterol suplementation can modify LDL subfractions'}, {'measure': 'Change in HDL subfractions', 'timeFrame': '12 weeks', 'description': 'Phytosterol suplementation can modify HDL subfractions'}, {'measure': 'Improvement on quality of LDL particle', 'timeFrame': '12 weeks', 'description': 'Phytosterol supplementation can improve the quality of LDL particle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phytosterols', 'Lipoproteins', 'LDL-subfractions', 'HDL-subfractions'], 'conditions': ['Hypercholesterolemia', 'Primary Prevention']}, 'referencesModule': {'references': [{'pmid': '38750162', 'type': 'DERIVED', 'citation': 'Machado VA, Santisteban ARN, Martins CM, Damasceno NRT, Fonseca FA, Neto AMF, Izar MC. Effects of phytosterol supplementation on lipoprotein subfractions and LDL particle quality. Sci Rep. 2024 May 15;14(1):11108. doi: 10.1038/s41598-024-61897-4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects.\n\nThe main questions it aims to answer are:\n\n* do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?\n* do phytosterols modify the quality of LDL?\n\nParticipants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.', 'detailedDescription': 'Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.\n\nStudy was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.\n\nAnthropometry, food consumption and laboratory parameters were evaluated every 12-w.\n\nHDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).\n\nPlasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants of both sexes, aged \\>18 and \\<65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and \\<190 mg/dL and triglycerides \\<400 mg/dL.\n\nExclusion Criteria:\n\n* secondary causes of dyslipidemia, renal (creatinine \\> 2mg/dL), hepatic (AST or ALT \\> 1.5 ULN), or metabolic (HbA1c \\>8.0%) dysfunction, with BMI \\<18.5 or \\>40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols'}, 'identificationModule': {'nctId': 'NCT06127732', 'acronym': 'Phyto', 'briefTitle': 'Phytosterol Supplementation and Lipoprotein Subfractions', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study', 'orgStudyIdInfo': {'id': '042778/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phytosterol', 'description': 'Participants received diet plus phytosterols (2.6 g of phytosterols per day) prescribed and supplied in 650 mg gelatin capsules, to be used four capsules a day along with meals(Fitocor®, Farmoquímica, Brazil) and divided into two meals.for 12 weeks.', 'interventionNames': ['Dietary Supplement: Phytosterol supplements']}, {'type': 'NO_INTERVENTION', 'label': 'Control: diet alone', 'description': 'Participants received diet alone recommended for 12 weeks.'}], 'interventions': [{'name': 'Phytosterol supplements', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants were randomized into two groups to receive diet plus phytosterols (DP) for 12 weeks, followed by a 7-day washout period with a second period of intervention, where treatments were switched, and participants received diet alone (D) and were followed for another 12 weeks.', 'armGroupLabels': ['Phytosterol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'Other', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04039030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Maria C Izar, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After publication, and for one year.', 'ipdSharing': 'YES', 'description': 'IPD will be shared upon request.', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Maria Cristina de Oliveira Izar', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}