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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Yeast beta-glucan

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

Group Type EXPERIMENTAL

Yeast beta-glucan

Intervention Type DIETARY_SUPPLEMENT

Produced by Angel Yeast Co., LTD

Starch

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

Group Type PLACEBO_COMPARATOR

Starch

Intervention Type DIETARY_SUPPLEMENT

Produced by Angel Yeast Co., LTD

Interventions

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Yeast beta-glucan

Produced by Angel Yeast Co., LTD

Intervention Type DIETARY_SUPPLEMENT

Starch

Produced by Angel Yeast Co., LTD

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes