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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yeast beta-glucan | Experimental | Yeast beta-glucan capsules, 250mg,taken with meals, two capsules twice a day |
|
| Starch | Placebo Comparator | Starch capsule, 250mg, taken with meals, two capsules twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yeast beta-glucan | Dietary Supplement | Produced by Angel Yeast Co., LTD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment, MOCA | 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. | up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota, fecal SCFAs and SIgA | 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). | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofan Xu, Master | School of Public Health, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinopharm Dongfeng General Hospital | Shiyan | Hubei | 442000 | China | ||
| Huazhong University of Science and Technology |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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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.
| Starch |
| Dietary Supplement |
Produced by Angel Yeast Co., LTD |
|
| 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 | 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. | up to 7 months |
| Plasma Aβ-40, Aβ-42 | The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA | up to 2 years |
| Clock Drawing Test | To assess visual space and executive ability. Higher scores mean a better outcome. | up to 7 months |
| Digital Span Test | Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome. | up to 7 months |
| Trail Making Test | To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result. | up to 7 months |
| Verbal Fluency Test | To assess verbal fluency. Higher scores mean a better outcome. | up to 7 months |
| Digit Symbol Substitution Test | To assess reaction speed. Higher scores mean a better outcome. | up to 7 months |
| Wuhan |
| Hubei |
| 430000 |
| China |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |