Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-03 @ 1:27 AM
Study NCT ID:
NCT02969720
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2016-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010840', 'term': 'Phytosterols'}, {'id': 'C009495', 'term': 'titanium dioxide'}], 'ancestors': [{'id': 'D013261', 'term': 'Sterols'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D064209', 'term': 'Phytochemicals'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-14', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome x']}, 'referencesModule': {'references': [{'pmid': '32785036', 'type': 'DERIVED', 'citation': 'Palmeiro-Silva YK, Aravena RI, Ossio L, Parro Fluxa J. Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2020 Aug 10;12(8):2392. doi: 10.3390/nu12082392.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent written\n* Available subjects to follow-up visits\n* Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria\n* Subjects with health visits ongoing\n* Subjects with arterial hypertension under control.\n* Subjects with mellitus diabetes under control.\n\nExclusion Criteria:\n\n* Subjects with alcoholism history.\n* Subjects with history of sitosterolemia.\n* Subjects with familiar hypercholesterolemia\n* Subjects who are consuming phytosterols\n* Pregnancy women\n* Breastfeeding period women\n* Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation'}, 'identificationModule': {'nctId': 'NCT02969720', 'acronym': 'FESIME', 'briefTitle': 'Therapeutic Efficacy of Phytosterols on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de los Andes, Chile'}, 'officialTitle': 'Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'FESIME-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phytosterol', 'description': 'Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.', 'interventionNames': ['Dietary Supplement: Phytosterols']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.', 'interventionNames': ['Dietary Supplement: Titanium Dioxide']}], 'interventions': [{'name': 'Phytosterols', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cardiosmile'], 'description': 'Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.', 'armGroupLabels': ['Phytosterol']}, {'name': 'Titanium Dioxide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Universidad de Los Andes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'PI will share IPD after doing all possible publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de los Andes, Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Professor', 'investigatorFullName': 'Yasna Palmeiro-Silva', 'investigatorAffiliation': 'Universidad de los Andes, Chile'}}}}