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Not Yet Recruiting NCT05741047

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

Conditions: Mild Cognitive Impairment, Adults

Sex: All
Ages: 65 Years – 75 Years
Phase: NA
Enrollment: 96
Sponsor: a2 Milk Company Ltd.

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.

Eligibility Criteria

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 educationLiving 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 consentParticipants must be excluded from the study if they meet any of the following criteria:<65 years; or >75 yearsNeurological 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05741047). StuddyBuddy aggregates publicly available trial information.