Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-31 @ 5:56 AM
Study NCT ID:
NCT05680532
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic indices', 'timeFrame': '8 weeks', 'description': 'No significant changes in any of the glycemic indices'}, {'measure': 'Anthropometric parameters', 'timeFrame': '8 weeks', 'description': 'BMI were significantly altered'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['black raspberry', "Alzheimer's patients", 'H pylori', 'Inflammatory cytokines', 'Antioxidant'], 'conditions': ['Alzheimer Disease', 'H Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '39939643', 'type': 'DERIVED', 'citation': 'Tandoro Y, Chiu HF, Tan CL, Hsieh MH, Huang YW, Yu J, Wang LS, Chan CH, Wang CK. Black raspberry supplementation on overweight and Helicobacter pylori infected mild dementia patients a pilot study. NPJ Sci Food. 2025 Feb 12;9(1):9. doi: 10.1038/s41538-024-00356-w.'}]}, 'descriptionModule': {'briefSummary': 'The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.', 'detailedDescription': 'The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).\n\nPreclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.\n\nFor the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.\n\nExperimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,\n* Body fat: male ≧ 25%, female ≧ 30%,\n* UBT 13C test value\\> 10‰ (H. pylori (+)),\n* CDR (clinical dementia rating) = 0.5\n\nExclusion Criteria:\n\n* BMI\\< 27\n* Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)\n* Alcohol abuse\n* Smoking habit\n* Taking berry-related supplementation or any known allergies related to berries.\n* Subjects with prior history of H. pylori infection were treated with triple therapy.'}, 'identificationModule': {'nctId': 'NCT05680532', 'acronym': 'BR', 'briefTitle': 'The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori', 'orgStudyIdInfo': {'id': 'CS2-21103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BR group', 'description': 'Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.', 'interventionNames': ['Dietary Supplement: Black raspberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Black raspberry', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.', 'armGroupLabels': ['BR group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'state': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chin-Kun Wang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chin Kun Wang', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}