Mild Cognitive Impairment, Alzheimer Disease
Conditions
Keywords
Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTYeast beta-glucan
Produced by Angel Yeast Co., LTD
DIETARY_SUPPLEMENTStarch
Produced by Angel Yeast Co., LTD
Sponsors
Xiaofan Xu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment, MOCA | up to 7 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 7 months | 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. |
| Plasma Aβ-40, Aβ-42 | up to 2 years | The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA |
| Clock Drawing Test | up to 7 months | To assess visual space and executive ability. Higher scores mean a better outcome. |
| Gut microbiota, fecal SCFAs and SIgA | up to 2 years | 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). |
| Trail Making Test | up to 7 months | To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result. |
| Verbal Fluency Test | up to 7 months | To assess verbal fluency. Higher scores mean a better outcome. |
| Digit Symbol Substitution Test | up to 7 months | To assess reaction speed. Higher scores mean a better outcome. |
| Digital Span Test | up to 7 months | Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome. |
Countries
China
Outcome results
None listed