- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06083350
Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
October 11, 2023 updated by: Xiaofan Xu
A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Shiyan, Hubei, China, 442000
- Sinopharm Dongfeng General Hospital
-
Wuhan, Hubei, China, 430000
- Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yeast beta-glucan
Yeast beta-glucan capsules, 250mg,taken with meals, two capsules twice a day
|
Produced by Angel Yeast Co., LTD
|
Placebo Comparator: Starch
Starch capsule, 250mg, taken with meals, two capsules twice a day
|
Produced by Angel Yeast Co., LTD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Cognitive Assessment, MOCA
Time Frame: 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.
|
up to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut microbiota, fecal SCFAs and SIgA
Time Frame: 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).
|
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
Time Frame: 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.
|
up to 7 months
|
Plasma Aβ-40, Aβ-42
Time Frame: up to 2 years
|
The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA
|
up to 2 years
|
Clock Drawing Test
Time Frame: up to 7 months
|
To assess visual space and executive ability.
Higher scores mean a better outcome.
|
up to 7 months
|
Digital Span Test
Time Frame: up to 7 months
|
Attention and short-term memory are assessed by Digital Span Test.
Higher scores mean a better outcome.
|
up to 7 months
|
Trail Making Test
Time Frame: 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.
|
up to 7 months
|
Verbal Fluency Test
Time Frame: up to 7 months
|
To assess verbal fluency.
Higher scores mean a better outcome.
|
up to 7 months
|
Digit Symbol Substitution Test
Time Frame: up to 7 months
|
To assess reaction speed.
Higher scores mean a better outcome.
|
up to 7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaofan Xu, Master, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2023
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
October 11, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HuazhongU-XXu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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