Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-20 @ 2:22 AM
Study NCT ID:
NCT05423457
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diets, Lipoproteins and Inflammation Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration', 'timeFrame': '12 weeks', 'description': 'GlycA (umol/L), lipoprotein particles concentration(umol/L)'}, {'measure': 'Lipoprotein particles concentration', 'timeFrame': '12 weeks', 'description': 'lipoprotein particles concentration (nmol/L）'}, {'measure': 'lipoprotein particles size', 'timeFrame': '12 weeks', 'description': 'lipoprotein particles size (nm)'}, {'measure': 'Trimethylamine-N-oxide', 'timeFrame': '12 weeks', 'description': 'TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides'}, {'measure': 'Traditional cadiometabolic risk factors 1', 'timeFrame': '12 weeks', 'description': 'TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)'}, {'measure': 'Traditional cadiometabolic risk factors 2', 'timeFrame': '12 weeks', 'description': 'HbA1c(%)'}, {'measure': 'Traditional cadiometabolic risk factors 3', 'timeFrame': '12 weeks', 'description': 'HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Metabolic Syndrome', 'Diet, Healthy', 'Vegan Diet', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).\n\nAim:\n\nTo compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.\n\nDesign: Randomized crossover design'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with dyslipidemia (at least one of the following)\n\n* TG ≥ 150 mg/dL\n* TC ≥ 200 mg/dL\n* LDL-c≥ 130 mg/dL,\n* HDL-c \\< 45 mg/dL for male or \\< 55 mg/dL for female or receiving statin treatment\n\nExclusion Criteria (fulfill one of the following condition):\n\n* chronic kidney disease\n* history of coronary artery disease\n* ischemic heart disease,\n* heart failure,\n* stroke,\n* cancer of any type'}, 'identificationModule': {'nctId': 'NCT05423457', 'briefTitle': 'Diets, Lipoproteins and Inflammation Markers', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors', 'orgStudyIdInfo': {'id': 'IRB106-92-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan diet', 'description': 'Participants were provided with and instructed to eat these foods:\n\n* flaxseed meal,\n* walnuts,\n* pecans,\n* extra-virgin olive oil,\n* Brazil nuts\n* Taiwanese purple laver (also known as "hong-mao-tai" or Bangia atropurpurea, and was selected to test for its vitamin B12 bioavailability).\n\nEach Participant has three group sessions and three individual nutrition counseling with a dietitian.', 'interventionNames': ['Behavioral: Vegan diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MyPlate (Taiwanese version)', 'description': 'Each Participant has three group sessions and three individual nutrition counseling with a dietitian.', 'interventionNames': ['Behavioral: Vegan diet']}], 'interventions': [{'name': 'Vegan diet', 'type': 'BEHAVIORAL', 'description': 'The participants were advised to eat foods in their original type.', 'armGroupLabels': ['MyPlate (Taiwanese version)', 'Vegan diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Hualien Tzu Chi Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}