Clinical trial NCT06083350: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: Mild Cognitive Impairment
Alzheimer Disease
Montreal Cognitive Assessment
Gut microbiota
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 144
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Montreal Cognitive Assessment, MOCA
timeFrame: up to 7 months
Secondary outcomes:
measure: Gut microbiota, fecal SCFAs and SIgA
timeFrame: up to 2 years
measure: 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
timeFrame: up to 7 months
measure: Plasma Aβ-40, Aβ-42
timeFrame: up to 2 years
measure: Clock Drawing Test
timeFrame: up to 7 months
measure: Digital Span Test
timeFrame: up to 7 months
measure: Trail Making Test
timeFrame: up to 7 months
measure: Verbal Fluency Test
timeFrame: up to 7 months
measure: Digit Symbol Substitution Test
timeFrame: up to 7 months
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Sinopharm Dongfeng General Hospital
state: Hubei
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
name: Xiaofan Xu, Master
role: PRINCIPAL_INVESTIGATOR
References: