NCT05741047已完成不适用
Comparing the Effect of Powdered Skim Milk Containing A2 β-casein Only Versus Conventional Powdered Skim Milk Containing A1 and A2 β-caseins on Mild Cognitive Impairment in Older Adults: a Double-blind, Randomized, Controlled Trial
a2 Milk Company Ltd.2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline
研究概览
简要总结
The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition, inflammation, and dietary intake in adults aged 65-75 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study, participants must meet all of the following criteria:
- •Adults aged 65-75 years;
- •Complaint of memory loss for more than 6 months;
- •Base on the Chinese version of Mini Mental State Examination (MMSE), cognitive ability score is lower than the standard cut-off value according to age and education levels: MMSE score≤ 17 points if years of education is 0 year; ≤ 20 points if 6 years or less of education; ≤ 24 points if more than 6 years of education
- •Living and social functions are reduced: activities of daily living (ADL) score ≤18;
- •Not meeting the diagnostic criteria for dementia (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition), Alzheimer Disease (National Stroke Institute for Neuropathic Speech Disorders and Association for Alzheimer Disease and Related Disorders); no mental disorder, brain damage, or other physical disorders that can lead to cognitive impairment.
- •Agreed not to participate in another interventional clinical research study during the present study;
- •Signed informed consent
- •Participants must be excluded from the study if they meet any of the following criteria:
- •<65 years; or >75 years
- •Neurological examination showed focal signs of central nervous system disorder such as hemiplegia, dysesthesia, aphasia; history of cerebrovascular diseases (including hemorrhagic and ischemic types), internal brain trauma or fracture;
- •Asthmatic bronchitis, severe hypertension, angina and severe infection;
- •Mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis);
- •Newly diagnosed, progressing or advanced tumors;
- •Visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests;
- •History of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function;
- •Neurological diseases (e.g. Parkinson's disease, epilepsy);
- •Antibiotic treatment in previous 2 weeks;
- •Administered immunosuppressive drugs in the 4-weeks preceding screening;
- •Allergy to milk or dairy;
- •Diagnosed lactose intolerance;
- •Other diseases that investigators judged as unsuitable to participate the study.
排除标准
- 未提供
结局指标
主要结局
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline
时间窗: Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Record responding time and speed on the SCIT test
Changes of serum glutathione (GSH) at Visit 2 and Visit 4 compared to baseline
时间窗: Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Record serum glutathione (GSH) (µmol/L) as an anti-oxidation marker
次要结局
- Changes of C-reactive protein at Visit 2 and 4 compared to baseline(Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment))
- Changes of short-chain fatty acids at Visit 2, 3, and 4 compared to baseline(Visit 2 (14 days after baseline); Visit 3 (28 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment))
- Changes of quality of life at Visit 4 compared to baseline(Visit 4 (90 days after baseline); baseline (14 days after enrolment))
研究者
研究点 (2)
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