Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: a2 Group The group consuming a2Milk skim milk powder (1L) containing A2 β-casein only |
Other: a2Milk skim milk powder
a2Milk skim milk powder (1L) containing A2 β-casein only
Other Names:
|
| Placebo Comparator: Control Group The group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins |
Other: Yili skim milk powder
Yili skim milk powder (1L) containing A1 and A2 β-caseins
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline [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 [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
Secondary Outcome Measures
- 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)]
Record short-chain fatty acids (mg/g) as a faecal marker of inflammation
- Changes of quality of life at Visit 4 compared to baseline [Visit 4 (90 days after baseline); baseline (14 days after enrolment)]
Record Healthy Brain Ageing - Functional Assessment Questionnaire via patient self-report as a quality of life measure
- 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)]
Record C-reactive protein (mg/L) as a blood marker of inflammation
Eligibility Criteria
Criteria
For inclusion in the study, participants must meet all of the following criteria:
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Adults aged 65-75 years;
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Complaint of memory loss for more than 6 months;
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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
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Living and social functions are reduced: activities of daily living (ADL) score ≤18;
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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.
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Agreed not to participate in another interventional clinical research study during the present study;
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Signed informed consent
Participants must be excluded from the study if they meet any of the following criteria:
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<65 years; or >75 years
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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;
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Asthmatic bronchitis, severe hypertension, angina and severe infection;
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Mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis);
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Newly diagnosed, progressing or advanced tumors;
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Visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests;
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History of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function;
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Neurological diseases (e.g. Parkinson's disease, epilepsy);
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Antibiotic treatment in previous 2 weeks;
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Administered immunosuppressive drugs in the 4-weeks preceding screening;
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Allergy to milk or dairy;
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Diagnosed lactose intolerance;
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Other diseases that investigators judged as unsuitable to participate the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- a2 Milk Company Ltd.
- Edanz Group Japan Ltd
- Beijing Esmile Technology Co. Ltd.
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Investigators
- Principal Investigator: Keming Zhang, MD, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A2MC-G190549358