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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
Produced by Angel Yeast Co., LTD
Produced by Angel Yeast Co., LTD
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, China
Huazhong University of Science and Technology
Wuhan, Hubei, China
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.
Time frame: up to 7 months
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).
Time frame: 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.
Time frame: up to 7 months
Plasma Aβ-40, Aβ-42
The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA
Time frame: up to 2 years
Clock Drawing Test
To assess visual space and executive ability. Higher scores mean a better outcome.
Time frame: up to 7 months
Digital Span Test
Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.
Time frame: up to 7 months
Trail Making Test
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To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result.
Time frame: up to 7 months
Verbal Fluency Test
To assess verbal fluency. Higher scores mean a better outcome.
Time frame: up to 7 months
Digit Symbol Substitution Test
To assess reaction speed. Higher scores mean a better outcome.
Time frame: up to 7 months