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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05741047
• Other study ID #: A2MC-G190549358
• Status: Completed
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: a2 Milk Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adults
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• a2Milk skim milk powder
a2Milk skim milk powder (1L) containing A2 ß-casein only
• Yili skim milk powder
Yili skim milk powder (1L) containing A1 and A2 ß-caseins

Locations

Country	Name	City	State
China	General Hospital of Tianjin Medical University	Tianjin
China	The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)