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Comparing the effect of powdered skim milk containing A2 ß-casein only versus conventional powdered skim milk containing A1 and A2 ß-caseins on mild cognitive impairment in older adults: a two-phase, double-blind, randomized, controlled trial

Comparing the effect of powdered skim milk containing A2 ß-casein only versus conventional powdered skim milk containing A1 and A2 ß-caseins on mild cognitive impairment in older adults: a two-phase, double-blind, randomized, controlled trial - Effect of A2 skimmed milk powder on mild cognitive impairment in the elderly

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069377
Enrollment
Unknown
Registered
2023-03-15
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment

Interventions

Intervention Group:a2 skimmed milk powder
Control Group:Yili skimmed milk powder

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 65-75 years; 2. Complaint of memory loss for more than 6 months; 3. 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 4. Living and social functions are reduced: activities of daily living (ADL) score <= 18; 5. 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. 6. Agreed not to participate in another interventional clinical research study during the present study; 7. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. 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; 2. Asthmatic bronchitis, severe hypertension, angina and severe infection; 3. Mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis); 4. Newly diagnosed, progressing or advanced tumors; 5. Visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests; 6. History of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function; 7. Neurological diseases (e.g. Parkinson's disease, epilepsy); 8. Antibiotic treatment in previous 2 weeks; 9. Administered immunosuppressive drugs in the 4-weeks preceding screening; 10. Allergy to milk or dairy; 11. Diagnosed lactose intolerance; 12. Other diseases that investigators judged as unsuitable to participate the study.

Design outcomes

Primary

MeasureTime frame
Subtle Cognitive Impairment Test (SCIT);glutathione;

Secondary

MeasureTime frame
calprotectin (S100A8/A9);myeloperoxidase;Short chain fatty acids, SCFAs;C-reactive protein, CRP;IL-1ß;IL-4;IL-8;TNF-a;IgE;IgG1;IgG2A;ß-tyrophin-7, BCM-7;galactose (qualitative test);Cyclophosphamide, CTX;osteocalcin;calcium;25-hydroxyvitamin D3, 25-OH-D3;grip;Montreal Cognitive Assessment Scale, MoCA;Auditory Verbal learning test, AVLT;Healthy Brain Ageing - Functional Assessment Questionnaire;

Countries

China

Contacts

Public ContactKeming Zhang

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

zzkkmmxx@163.com+86 155 2221 1995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026