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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06083350
• Other study ID #: HuazhongU-XXu
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: June 30, 2025
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Yeast beta-glucan
Produced by Angel Yeast Co., LTD
• Starch
Produced by Angel Yeast Co., LTD

Locations

Country	Name	City	State
China	Sinopharm Dongfeng General Hospital	Shiyan	Hubei
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaofan Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	T/B/NK cells and IL-1ß,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17,IFN-? and TNF-a 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-1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-?, and TNF-a are measured by Cytometric Bead Array (CBA) technology.	up to 7 months
Secondary	Plasma Aß-40, Aß-42	The plasma levels of Aß-40 and Aß-42 were detected by ELISA	up to 2 years
Secondary	Clock Drawing Test	To assess visual space and executive ability. Higher scores mean a better outcome.	up to 7 months
Secondary	Digital Span Test	Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.	up to 7 months
Secondary	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
Secondary	Verbal Fluency Test	To assess verbal fluency. Higher scores mean a better outcome.	up to 7 months
Secondary	Digit Symbol Substitution Test	To assess reaction speed. Higher scores mean a better outcome.	up to 7 months