A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment, MOCA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50-80 years;
- •Permanent residents of Shiyan City;
- •Meet the diagnostic criteria of MCI:
- •Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent;
- •Did not participate in other clinical trials in the past 3 months.
排除标准
- •Alcohol or drug abuse;
- •Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.;
- •History of severe head trauma;
- •Severe sensory and perceptual impairment, unable to complete the cognitive function measurement;
- •History of mental illness such as depression, mania, anxiety, or take psychiatric drugs;
- •Serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.;
- •Suffering from autoimmune diseases;
- •Trauma, spinal injury or any disease that may affect the motor function of the limb;
- •Recent infectious diseases, acute gastrointestinal diseases;
- •Take antibiotics, probiotics, prebiotics or biostime products within the last 1 month.
结局指标
主要结局
Montreal Cognitive Assessment, MOCA
时间窗: 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.
次要结局
- 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(up to 7 months)
- Digit Symbol Substitution Test(up to 7 months)
- Trail Making Test(up to 7 months)
- Verbal Fluency Test(up to 7 months)
- Gut microbiota, fecal SCFAs and SIgA(up to 2 years)
- Plasma Aβ-40, Aβ-42(up to 2 years)
- Clock Drawing Test(up to 7 months)
- Digital Span Test(up to 7 months)
研究者
Xiaofan Xu
Principal Investigator
Huazhong University of Science and Technology