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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05741047
Enrollment
96
Registered
2023-02-23
Start date
2023-03-07
Completion date
2023-10-13
Last updated
2023-10-19

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

Conditions

Adults, Mild Cognitive Impairment

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.

Interventions

OTHERa2Milk skim milk powder

a2Milk skim milk powder (1L) containing A2 β-casein only

OTHERYili skim milk powder

Yili skim milk powder (1L) containing A1 and A2 β-caseins

Sponsors

Edanz Group Japan Ltd
CollaboratorUNKNOWN
Beijing Esmile Technology Co. Ltd.
CollaboratorUNKNOWN
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
a2 Milk Company Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

For inclusion in the study, participants must meet all of the following 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 Participants must be excluded from the study if they meet any of the following criteria: 1. \<65 years; or \>75 years 2. 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; 3. Asthmatic bronchitis, severe hypertension, angina and severe infection; 4. Mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis); 5. Newly diagnosed, progressing or advanced tumors; 6. Visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests; 7. History of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function; 8. Neurological diseases (e.g. Parkinson's disease, epilepsy); 9. Antibiotic treatment in previous 2 weeks; 10. Administered immunosuppressive drugs in the 4-weeks preceding screening; 11. Allergy to milk or dairy; 12. Diagnosed lactose intolerance; 13. Other diseases that investigators judged as unsuitable to participate the study.

Design outcomes

Primary

MeasureTime frameDescription
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baselineVisit 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 baselineVisit 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

MeasureTime frameDescription
Changes of short-chain fatty acids at Visit 2, 3, and 4 compared to baselineVisit 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 baselineVisit 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 baselineVisit 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026