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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: Yeast beta-glucan; Dietary supplement: Starch

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Sinopharm Dongfeng General Hospital
    • Wuhan, Hubei, China, 430000
      • Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiaofan Xu
• Investigators: Principal Investigator: Xiaofan Xu, Master, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Alzheimer Disease; Montreal Cognitive Assessment; Gut microbiota
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: HuazhongU-XXu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No