Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT06448234
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in LDL-C', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'Percent change in high-sensitivity C-reactive protein (', 'timeFrame': '180 days'}, {'measure': 'Percent change in high-density lipoprotein cholesterol', 'timeFrame': '180 days'}, {'measure': 'Percent change in total cholesterol.', 'timeFrame': '180 days'}, {'measure': 'Percent change in serum triglycerides between the groups.', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LDL cholesterol reduction', 'AI-guided prescriptions', 'Dietary supplements', 'Personalized nutrition'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The trial compared AI-guided and standard physician-guided dietary supplement (DS) prescriptions for lowering LDL cholesterol (LDL-C) in hypercholesterolemic patients. The AI system used genetic, metabolic, and clinical data to personalize DS regimens, hypothesizing superior efficacy over traditional methods. This 3-month randomized, controlled trial involved adults aged 40-75 with specific LDL-C levels, excluding those with significant health risks. Participants were divided into a control group with physician-guided DS and an AI-guided group. The AI system from Triangel Scientific provided dynamic, personalized recommendations. Baseline and follow-up measurements included lipid profiles and adherence assessments. The AI-guided group showed significantly greater LDL-C reduction and improvement in other lipid markers. The study concluded that AI-guided DS prescriptions are more effective, suggesting a promising future for AI in personalized cholesterol management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 75 years.\n* LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.\n\nExclusion Criteria:\n\n* Personal history of cardiovascular disease or high risk (≥ 20%).\n\n * Triglycerides (TG) ≥ 400 mg/dL.\n * Body Mass Index (BMI) ≥ 35 kg/m²\n * Use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.\n * Diabetes mellitus.\n * Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.'}, 'identificationModule': {'nctId': 'NCT06448234', 'briefTitle': 'Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients', 'organization': {'class': 'OTHER', 'fullName': 'S.LAB (SOLOWAYS)'}, 'officialTitle': 'Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'SW012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.', 'interventionNames': ['Other: Standart supplementation therapy group']}, {'type': 'EXPERIMENTAL', 'label': 'AI-Guided Group', 'description': 'Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.', 'interventionNames': ['Other: AI-guided supplementation therapy group']}], 'interventions': [{'name': 'Standart supplementation therapy group', 'type': 'OTHER', 'description': 'Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles', 'armGroupLabels': ['Control Group']}, {'name': 'AI-guided supplementation therapy group', 'type': 'OTHER', 'description': 'Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.', 'armGroupLabels': ['AI-Guided Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'state': 'Novosibisk Region', 'country': 'Russia', 'facility': 'Center of New Medical Technologies', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.LAB (SOLOWAYS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center of New Medical Technologies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}