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

NCT06083350 | Active Not Recruiting DMC

• 1 other identifier: HuazhongU-XXu
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

Mild Cognitive Impairment; Alzheimer Disease; Montreal Cognitive Assessment; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Gut microbiota, fecal SCFAs and SIgA

  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

  up to 7 months

• Plasma Aβ-40, Aβ-42

  up to 2 years

• Clock Drawing Test

  up to 7 months

• Digital Span Test

  up to 7 months

Study Arms (2)

Yeast beta-glucan

EXPERIMENTAL

Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day

Dietary Supplement: Yeast beta-glucan

Starch

PLACEBO COMPARATOR

Starch capsule, 250mg, taken with meals, two capsules twice a day

Dietary Supplement: Starch

Interventions

Yeast beta-glucan DIETARY_SUPPLEMENT

Produced by Angel Yeast Co., LTD

Yeast beta-glucan

Starch DIETARY_SUPPLEMENT

Produced by Angel Yeast Co., LTD

Starch

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xiaofan Xu: lead

Study Sites (2)

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, 442000, China

Location

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Starch

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Xiaofan Xu, Master

  School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 16, 2023
• Study Start: June 27, 2023
• Primary Completion: February 5, 2024
• Study Completion: June 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)