Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT03649620
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Total cholesterol', 'timeFrame': '12 weeks', 'description': 'Changes of total cholesterol were assessed before and after the intervention'}], 'secondaryOutcomes': [{'measure': 'Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)', 'timeFrame': '12 weeks', 'description': 'Changes of lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP) were assessed before and after the intervention'}, {'measure': 'Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)', 'timeFrame': '12 weeks', 'description': 'Changes of arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1) were assessed before and after the intervention'}, {'measure': 'Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)', 'timeFrame': '12 weeks', 'description': 'Changes of anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) were assessed before and after the intervention'}, {'measure': 'Changes of Oxidized LDL', 'timeFrame': '12 weeks', 'description': 'Changes of oxidized LDL were assessed before and after the intervention'}]}, 'conditionsModule': {'keywords': ['cholesterol', 'Bokbunja', 'Clinical Trial'], 'conditions': ['Blood Cholesterol']}, 'referencesModule': {'references': [{'pmid': '32646501', 'type': 'DERIVED', 'citation': 'Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.', 'detailedDescription': 'This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 20 and 65 years,\n* Total cholesterol 200-239 mg/dl\n* subjects giving written informed consent\n\nExclusion Criteria:\n\n* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction\n* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery\n* Participation in any other clinical trials within past 2 months\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study\n* Pregnancy or breast feeding etc,.'}, 'identificationModule': {'nctId': 'NCT03649620', 'briefTitle': 'Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol', 'orgStudyIdInfo': {'id': 'BC_cholesterol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unripe Bokbunja Extract', 'description': 'tablet(1 tablet/d, 600 mg/d) for 12 weeks', 'interventionNames': ['Dietary Supplement: unripe Bokbunja Extract', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 12 weeks', 'interventionNames': ['Dietary Supplement: unripe Bokbunja Extract', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'unripe Bokbunja Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'tablet(1 tablet/d, 600 mg/d) for 12 weeks', 'armGroupLabels': ['Placebo', 'unripe Bokbunja Extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo for 12 weeks', 'armGroupLabels': ['Placebo', 'unripe Bokbunja Extract']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Principal Investigator', 'investigatorFullName': 'Jong Ho Lee', 'investigatorAffiliation': 'Yonsei University'}}}}