Back to resultsEffects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment, Alzheimer Disease
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yeast beta-glucan
Starch
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota
Eligibility Criteria
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.
Sites / Locations
- Sinopharm Dongfeng General Hospital
- Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Yeast beta-glucan
Starch
Arm Description
Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day
Starch capsule, 250mg, taken with meals, two capsules twice a day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Plasma Aβ-40, Aβ-42
The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA
Clock Drawing Test
To assess visual space and executive ability. Higher scores mean a better outcome.
Digital Span Test
Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.
Trail Making Test
To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result.
Verbal Fluency Test
To assess verbal fluency. Higher scores mean a better outcome.
Digit Symbol Substitution Test
To assess reaction speed. Higher scores mean a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06083350
Brief Title
Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
Official Title
A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaofan Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease
Keywords
Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yeast beta-glucan
Arm Type
Experimental
Arm Description
Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day
Arm Title
Starch
Arm Type
Placebo Comparator
Arm Description
Starch capsule, 250mg, taken with meals, two capsules twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Yeast beta-glucan
Intervention Description
Produced by Angel Yeast Co., LTD
Intervention Type
Dietary Supplement
Intervention Name(s)
Starch
Intervention Description
Produced by Angel Yeast Co., LTD
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment, MOCA
Description
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.
Time Frame
up to 7 months
Secondary Outcome Measure Information:
Title
Gut microbiota, fecal SCFAs and SIgA
Description
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).
Time Frame
up to 2 years
Title
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
Description
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.
Time Frame
up to 7 months
Title
Plasma Aβ-40, Aβ-42
Description
The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA
Time Frame
up to 2 years
Title
Clock Drawing Test
Description
To assess visual space and executive ability. Higher scores mean a better outcome.
Time Frame
up to 7 months
Title
Digital Span Test
Description
Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.
Time Frame
up to 7 months
Title
Trail Making Test
Description
To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result.
Time Frame
up to 7 months
Title
Verbal Fluency Test
Description
To assess verbal fluency. Higher scores mean a better outcome.
Time Frame
up to 7 months
Title
Digit Symbol Substitution Test
Description
To assess reaction speed. Higher scores mean a better outcome.
Time Frame
up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofan Xu, Master
Organizational Affiliation
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinopharm Dongfeng General Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
We'll reach out to this number within 24 hrs