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

Sponsor

Xiaofan Xu (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06083350

Collaborator

(none)

144

Enrollment

Locations

Arms

24.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Alzheimer Disease	Dietary Supplement: Yeast beta-glucan Dietary Supplement: Starch	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 27, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).
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.
Digital Span Test [up to 7 months]
Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. Aged 50-80 years;
1. Permanent residents of Shiyan City;
1. Meet the diagnostic criteria of MCI:
1. Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent;
1. Did not participate in other clinical trials in the past 3 months.

Exclusion Criteria:

1. Alcohol or drug abuse;
1. Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.;
1. History of severe head trauma;
1. Severe sensory and perceptual impairment, unable to complete the cognitive function measurement;
1. History of mental illness such as depression, mania, anxiety, or take psychiatric drugs;
1. Serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.;
1. Suffering from autoimmune diseases;
1. Trauma, spinal injury or any disease that may affect the motor function of the limb;
1. Recent infectious diseases, acute gastrointestinal diseases;
1. Take antibiotics, probiotics, prebiotics or biostime products within the last 1 month.