Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adults, Mild Cognitive Impairment

Intervention / Treatment
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* Other: a2Milk skim milk powder
* Other: Yili skim milk powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a2 Group<br>The group consuming a2Milk skim milk powder (1L) containing A2 β-casein only | Other: a2Milk skim milk powder<br>* a2Milk skim milk powder (1L) containing A2 β-casein only<br>* Other names: Treatment group;|
| Placebo Comparator: Control Group<br>The group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins | Other: Yili skim milk powder<br>* Yili skim milk powder (1L) containing A1 and A2 β-caseins<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline | Record responding time and speed on the SCIT test | Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment) | 
| Changes of serum glutathione (GSH) at Visit 2 and Visit 4 compared to baseline | Record serum glutathione (GSH) (µmol/L) as an anti-oxidation marker | Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of short-chain fatty acids at Visit 2, 3, and 4 compared to baseline | Record short-chain fatty acids (mg/g) as a faecal marker of inflammation | 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 | Record Healthy Brain Ageing - Functional Assessment Questionnaire via patient self-report as a quality of life measure | Visit 4 (90 days after baseline); baseline (14 days after enrolment) | 
| Changes of C-reactive protein at Visit 2 and 4 compared to baseline | Record C-reactive protein (mg/L) as a blood marker of inflammation | Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment) |