Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-22 @ 7:16 AM
Study NCT ID:
NCT02215694
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2014-08-02', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'LDL particle size at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Plasma LDL particle size (nm)'}, {'measure': 'Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum high-sensitivity C-reactive protein (mg/dL)'}], 'primaryOutcomes': [{'measure': 'ApoA5-1131 genotype', 'timeFrame': 'at baseline', 'description': 'ApoA5-1131 T\\>C'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum fasting glucose (mg/dL)'}, {'measure': 'Insulin at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum insulin (μIU/dL)'}, {'measure': 'C-peptide at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum C-peptide (μEq/L)'}, {'measure': 'Apolipoprotein A-V at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Plasma apolipoprotein A-V (ng/mL)'}, {'measure': 'Triglyceride at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum triglyceride (mg/dL)'}, {'measure': 'Free fatty acid at baseline and 12-week follow-up', 'timeFrame': '12-week follow-up', 'description': 'Serum free fatty acid (μEq/L)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Apolipoprotein A-V', 'LDL particle size', 'probiotic', 'triglyceride'], 'conditions': ['Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '26044516', 'type': 'DERIVED', 'citation': 'Ahn HY, Kim M, Ahn YT, Sim JH, Choi ID, Lee SH, Lee JH. The triglyceride-lowering effect of supplementation with dual probiotic strains, Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032: Reduction of fasting plasma lysophosphatidylcholines in nondiabetic and hypertriglyceridemic subjects. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):724-33. doi: 10.1016/j.numecd.2015.05.002. Epub 2015 May 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nondiabetic (plasma fasting glucose, \\<126mg/dL; 2-hour plasma glucose, \\<200mg/dL)\n* borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)\n\nExclusion Criteria:\n\n* lipid-lowering medications use\n* any medications or supplement use\n* any probiotics products use for the past 1 months\n* dyslipidemia\n* diabetes mellitus\n* hypertension\n* liver disease\n* renal disease\n* cardiovascular disease\n* cerebrovascular disease\n* pancreatitis\n* cancer\n* medication or alcohol abuse\n* pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT02215694', 'briefTitle': 'Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects', 'orgStudyIdInfo': {'id': 'probiotics_140801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotic group', 'description': 'consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)', 'interventionNames': ['Dietary Supplement: dual probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'consumed 2g of powder daily without probiotics', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'dual probiotics', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['probiotic'], 'description': '2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)', 'armGroupLabels': ['probiotic group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2g of powder daily without probiotics', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-749', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Laboratory of Clinical Nutrigenetics/Nutrigenomics', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Ho Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}