Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-28 @ 4:18 AM
Study NCT ID:
NCT03952169
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2019-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Lipid Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled, randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2019-05-12', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total cholesterol', 'timeFrame': 'baseline, 4 weeks, 8 weeks and 12 weeks', 'description': 'changes of total cholesterol levels in plasma by automatic biochemical analyzer'}, {'measure': 'LDL-cholesterol', 'timeFrame': 'baseline, 4 weeks, 8 weeks and 12 weeks', 'description': 'changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer'}, {'measure': 'Triglyceride', 'timeFrame': 'baseline, 4 weeks, 8 weeks and 12 weeks', 'description': 'changes of triglyceride levels in plasma by automatic biochemical analyzer'}, {'measure': 'non HDL-cholesterol', 'timeFrame': 'baseline, 4 weeks, 8 weeks and 12 weeks', 'description': 'changes of non HDL-cholesterol levels in plasma'}, {'measure': 'gut microbiota', 'timeFrame': 'baseline, 4 week, 8 weeks and 12 weeks', 'description': 'changes of gut microbiota by metagenomics'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'baseline, 4 week, 8 week and 12 weeks', 'description': 'changes of blood pressure'}, {'measure': 'pulse wave velocity', 'timeFrame': 'baseline and after 12-week intervention', 'description': 'changes of pulse wave velocity by VP-1000plus from Omron'}, {'measure': 'ankle Brachial Index', 'timeFrame': 'baseline and after 12-week intervention', 'description': 'changes of ankle Brachial Index by VP-1000plus from Omron'}, {'measure': 'microbial metabolite', 'timeFrame': 'baseline and after 12-week intervention', 'description': 'changes of microbial metabolite by untargeted metabolomics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Hypercholesterolemia', 'Probiotics', 'Cardiovascular risk'], 'conditions': ['Primary Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia in adults remain obscure.', 'detailedDescription': 'Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;\n* Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.\n\nExclusion Criteria:\n\n* Triglyceride levels higher than 3.95 mmol/L, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases;\n* Type 1 diabetes, type 2 diabetes treated with insulin or other medications;\n* Acute illness or current evidence of acute or chronic inflammatory or infective diseases;\n* Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;\n* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.'}, 'identificationModule': {'nctId': 'NCT03952169', 'briefTitle': 'Effect of Probiotics on Lipid Management', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Role of Probiotics in the Management of Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'ProHealth-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics group', 'description': 'Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.', 'interventionNames': ['Dietary Supplement: Lactobacillus paracasei dietary supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.', 'interventionNames': ['Other: Placebo controls']}], 'interventions': [{'name': 'Lactobacillus paracasei dietary supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a commercial probiotic dietary supplement', 'armGroupLabels': ['Probiotics group']}, {'name': 'Placebo controls', 'type': 'OTHER', 'description': 'placebo with a similar appearance to probiotics supplement', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Nutrition and Food Hygiene', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Min Xia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min Xia', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}