Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 8:43 AM
Study NCT ID:
NCT06083350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple blind, the unique codes of the intervention and placebo are known only to the person in charge of the intervention manufacturer (Anginute), not to the study implementors, investigators, subjects, data collectors and analysts, and are only unblinded by the manufacturer after the study is completed.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment, MOCA', 'timeFrame': 'up to 7 months', 'description': 'To assess overall cognitive function based on test scores. Patients with MOCA scores between 18 and 25 were included, and higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota, fecal SCFAs and SIgA', 'timeFrame': 'up to 2 years', 'description': '16S rRNA gene amplicon sequencing technique is used to determine species richness and diversity, species difference and functional prediction of gut microbiota; The content of SCFAs in fecal is determined by gas chromatography-mass spectrometry (GC-MS); Fecal SIgA is detected by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'T/B/NK cells and IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12p70，IL-17，IFN-γ and TNF-α in peripheral blood', 'timeFrame': 'up to 7 months', 'description': 'The types and absolute counts of T/B/NK cells in peripheral blood are detected by flow cytometry, Plasma levels of IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-γ, and TNF-α are measured by Cytometric Bead Array (CBA) technology.'}, {'measure': 'Plasma Aβ-40, Aβ-42', 'timeFrame': 'up to 2 years', 'description': 'The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA'}, {'measure': 'Clock Drawing Test', 'timeFrame': 'up to 7 months', 'description': 'To assess visual space and executive ability. Higher scores mean a better outcome.'}, {'measure': 'Digital Span Test', 'timeFrame': 'up to 7 months', 'description': 'Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.'}, {'measure': 'Trail Making Test', 'timeFrame': 'up to 7 months', 'description': 'To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result.'}, {'measure': 'Verbal Fluency Test', 'timeFrame': 'up to 7 months', 'description': 'To assess verbal fluency. Higher scores mean a better outcome.'}, {'measure': 'Digit Symbol Substitution Test', 'timeFrame': 'up to 7 months', 'description': 'To assess reaction speed. Higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Alzheimer Disease', 'Montreal Cognitive Assessment', 'Gut microbiota'], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'Patients with mild cognitive impairment aged 50-80 years old were recruited in Shiyan City, Hubei Province, and divided into intervention group and placebo group. They were given yeast β-glucan capsules and starch capsules, respectively, for 6 months, in order to explore whether yeast β-glucan can improve cognitive function of patients with mild cognitive impairment by regulating gut microbiota and its metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Aged 50-80 years;\n* 2\\. Permanent residents of Shiyan City;\n* 3\\. Meet the diagnostic criteria of MCI:\n* 4\\. Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent;\n* 5\\. Did not participate in other clinical trials in the past 3 months.\n\nExclusion Criteria:\n\n* 1\\. Alcohol or drug abuse;\n* 2\\. Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.;\n* 3\\. History of severe head trauma;\n* 4\\. Severe sensory and perceptual impairment, unable to complete the cognitive function measurement;\n* 5\\. History of mental illness such as depression, mania, anxiety, or take psychiatric drugs;\n* 6\\. Serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.;\n* 7\\. Suffering from autoimmune diseases;\n* 8\\. Trauma, spinal injury or any disease that may affect the motor function of the limb;\n* 9\\. Recent infectious diseases, acute gastrointestinal diseases;\n* 10\\. Take antibiotics, probiotics, prebiotics or biostime products within the last 1 month."}, 'identificationModule': {'nctId': 'NCT06083350', 'briefTitle': 'Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'HuazhongU-XXu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yeast beta-glucan', 'description': 'Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day', 'interventionNames': ['Dietary Supplement: Yeast beta-glucan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Starch', 'description': 'Starch capsule, 250mg, taken with meals, two capsules twice a day', 'interventionNames': ['Dietary Supplement: Starch']}], 'interventions': [{'name': 'Yeast beta-glucan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Produced by Angel Yeast Co., LTD', 'armGroupLabels': ['Yeast beta-glucan']}, {'name': 'Starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Produced by Angel Yeast Co., LTD', 'armGroupLabels': ['Starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Sinopharm Dongfeng General Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Xiaofan Xu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaofan Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaofan Xu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}