Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-22 @ 8:35 AM
Study NCT ID:
NCT03330366
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Allium Hookeri on Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of blood glucose during OGTT', 'timeFrame': '8 weeks', 'description': 'Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention'}], 'secondaryOutcomes': [{'measure': 'Changes of blood insulin', 'timeFrame': '8 week', 'description': 'Changes of blood insulin were assessed before and after the intervention'}, {'measure': 'Changes of C-peptide', 'timeFrame': '8 week', 'description': 'Changes of C-peptide were assessed before and after the intervention'}, {'measure': 'Changes of HbA1c', 'timeFrame': '8 week', 'description': 'Changes of HbA1c were assessed before and after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PreDiabetes']}, 'referencesModule': {'references': [{'pmid': '32631388', 'type': 'DERIVED', 'citation': 'Park SH, Bae UJ, Choi EK, Jung SJ, Lee SH, Yang JH, Kim YS, Jeong DY, Kim HJ, Park BH, Chae SW. A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes. BMC Complement Med Ther. 2020 Jul 6;20(1):211. doi: 10.1186/s12906-020-03005-3.'}]}, 'descriptionModule': {'briefSummary': 'The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.', 'detailedDescription': 'Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting glucose 100\\~126 mg/dl\n\nExclusion Criteria:\n\n* Significant variation in weight (more 10%) in the past 3 months\n* Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months\n* Type 1 diabetes or HbA1c\\>9.0%\n* Cardiovascular disease\n* Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT03330366', 'briefTitle': 'Effects of Allium Hookeri on Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects', 'orgStudyIdInfo': {'id': 'CTCF2_2015_AH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allium hookeri extract', 'description': 'take two capsules per day (486 mg/day) for 8 weeks', 'interventionNames': ['Dietary Supplement: Allium hookeri extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'take two capsules per day for 8 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Allium hookeri extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['AH'], 'description': 'take two capsules per day (486 mg/day) for 8 weeks', 'armGroupLabels': ['Allium hookeri extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take two capsules per day', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}