Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 10:55 PM
Study NCT ID:
NCT04029818
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Probiotic on LDL-cholesterol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '8 weeks', 'description': 'Levels of LDL-cholesterol in plasma'}], 'secondaryOutcomes': [{'measure': 'Total cholesterol', 'timeFrame': '8 weeks', 'description': 'Levels of total cholesterol in plasma'}, {'measure': 'HDL-cholesterol', 'timeFrame': '8 weeks', 'description': 'Levels of HDL-cholesterol in plasma'}, {'measure': 'Triglycerides', 'timeFrame': '8 weeks', 'description': 'Levels of triglycerides in plasma'}, {'measure': 'Glucose', 'timeFrame': '8 weeks', 'description': 'Levels of glucose in plasma'}, {'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': 'Systolic and diastolic pressure'}, {'measure': 'Body mass index', 'timeFrame': '8 weeks', 'description': "A person's weight in kilograms (kg) divided by his or her height in meters squared"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LDL-cholesterol', 'Probiotics'], 'conditions': ['Cardiovascular Diseases', 'LDL-cholesterol']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the ability of Bifidobacterium BSL\\_PS404 in reducing LDL-cholesterol levels in healthy individuals.', 'detailedDescription': 'There is a strong correlation between LDL-cholesterol and cardiovascular diseases.\n\nConjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.\n\nSeveral intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL\\_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Levels of LDL-cholesterol between 100 and 190 mg/dL.\n* Accept freely to participate in the study and sign the informed consent document.\n\nExclusion Criteria:\n\n* Be pregnant.\n* Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.\n* Having a serious illness.\n* Having diabetes.\n* Having a cerebrovascular disease.\n* Being allergic to any group of antibiotics.\n* Take probiotics in the form of supplements at least 4 weeks before.\n* Take antibiotics at least 4 weeks before.\n* Being taking products or drugs to control cholesterol levels'}, 'identificationModule': {'nctId': 'NCT04029818', 'briefTitle': 'Evaluation of a Probiotic on LDL-cholesterol Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosearch S.A.'}, 'officialTitle': 'Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'P046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Volunteers will take a capsule with Bifidobacterium BSL\\_PS404 (3x109 cfu) daily.', 'interventionNames': ['Biological: Bifidobacterium BSL_PS404']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Volunteers will take a capsule with maltodextrin daily.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Bifidobacterium BSL_PS404', 'type': 'BIOLOGICAL', 'description': 'Each participant will consume 1 capsule daily at lunch for 8 weeks.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Each participant will consume 1 capsule daily at lunch for 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Miguel Quesada, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical specialist in Endocrinology, Hospital San Cecilio de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosearch S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}