Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06657456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Phytosterol-Rich Extract on Lipid Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-10-19', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood lipid profile', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides'}], 'secondaryOutcomes': [{'measure': 'Anthropometric parameters', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Body weight (Kg), body mass index (kg/m\\^2) and waist circumference (cm)'}, {'measure': 'Body composition measures', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Fat-free mass (Kg) and fat mass (Kg)'}, {'measure': 'Oxidation markers', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Measurement of oxidized LDL'}, {'measure': 'Dietary Intake', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).'}, {'measure': 'Adherence to the Mediterranean diet', 'timeFrame': 'Day 1, at 28, and 56 days', 'description': 'Measurement of adherence to the Mediterranean diet by the MEDAS questionnaire.'}, {'measure': 'Blood pressure', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Systolic blood pressure and diastolic blood pressure (mmHg).'}, {'measure': 'Physical Activity', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'Measured by IPAQ/GPAQ questionnaire.'}, {'measure': 'Liver safety variables', 'timeFrame': 'Day 1, at 28 and 56 days', 'description': 'It is a blood test that measures liver enzymes, such as GPT (ALT) and GOT (AST), to evaluate liver function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholesterol', 'Cholesterol, Elevated', 'Hypercholesterolaemia', 'Lipid Metabolism Disorders', 'Dyslipidemias'], 'conditions': ['Cholesterol, Elevated', 'Hypercholesterolaemia', 'Lipid Metabolism Disorders', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.', 'detailedDescription': 'The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.\n\nSubjects will be randomized to each of the study arms (consumption of the experimental product or control product).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (age \\> 18 YO)\n* Total cholesterol levels at screening ≥ 200 mg/dL\n\nExclusion Criteria:\n\n* History of allergic hypersensitivity or poor tolerance to any component of the products under study.\n* Use of prescribed medication which may interfere with study measurements.\n* Unwillingness or inability to comply with clinical trial procedures.\n* Subjects whose condition makes them ineligible for the study at the investigator's discretion.\n* Pregnant or having the wish to become pregnant, or lactating.\n* Recent participation in another nutritional or medical trial"}, 'identificationModule': {'nctId': 'NCT06657456', 'briefTitle': 'Impact of Phytosterol-Rich Extract on Lipid Profile', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.', 'orgStudyIdInfo': {'id': 'CE102401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Consumption of dietary supplement capsules for 56 days.', 'interventionNames': ['Dietary Supplement: Phytosterol-rich extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Identically appearing placebo capsules consumed for 56 days.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Phytosterol-rich extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental product: extract rich in phytosterols', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Product with identical characteristics to the experimental product.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'UCAM San Antonio Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Desirée Victoria Montesinos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Católica San Antonio de Murcia'}, {'name': 'Ana Mª García Muñoz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Católica San Antonio de Murcia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Desirée Victoria Montesinos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Desirée Victoria Montesinos', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}