Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: Yeast beta-glucan
* Dietary Supplement: Starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Aged 50-80 years; 2. Permanent residents of Shiyan City; 3. Meet the diagnostic criteria of MCI: 4. Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent; 5. Did not participate in other clinical trials in the past 3 months. Exclusion Criteria: 1. Alcohol or drug abuse; 2. Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.; 3. History of severe head trauma; 4. Severe sensory and perceptual impairment, unable to complete the cognitive function measurement; 5. History of mental illness such as depression, mania, anxiety, or take psychiatric drugs; 6. Serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.; 7. Suffering from autoimmune diseases; 8. Trauma, spinal injury or any disease that may affect the motor function of the limb; 9. Recent infectious diseases, acute gastrointestinal diseases; 10. Take antibiotics, probiotics, prebiotics or biostime products within the last 1 month.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yeast beta-glucan<br>Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day | Dietary Supplement: Yeast beta-glucan<br>* Produced by Angel Yeast Co., LTD<br>|
| Placebo Comparator: Starch<br>Starch capsule, 250mg, taken with meals, two capsules twice a day | Dietary Supplement: Starch<br>* Produced by Angel Yeast Co., LTD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota