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

NCT05741047 | Completed DMC

• 1 other identifier: A2MC-G190549358
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment; Adults

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• 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)

• Changes of quality of life at Visit 4 compared to baseline

  Visit 4 (90 days after baseline); baseline (14 days after enrolment)

• 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)

Study Arms (2)

a2 Group

ACTIVE COMPARATOR

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

Other: a2Milk skim milk powder

Control Group

PLACEBO COMPARATOR

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

Other: Yili skim milk powder

Interventions

a2Milk skim milk powder OTHER

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

Also known as: Treatment group

a2 Group

Yili skim milk powder OTHER

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

Also known as: Control group

Control Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead
• Edanz Group Japan Ltd: collaborator
• Beijing Esmile Technology Co. Ltd.: collaborator
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

General Hospital of Tianjin Medical University

Tianjin, China

Location

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Related Publications (1)

• Zhang K, Sun J, Han M, Diao Y, Xia Y, Yang C, Robinson SR. Milk free of A1 beta-casein supports superior gains in cognition and quality of life, relative to conventional milk, in older adults with mild cognitive impairment. J Nutr Health Aging. 2025 Jul;29(7):100579. doi: 10.1016/j.jnha.2025.100579. Epub 2025 May 14.

  PMID: 40373392 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Keming Zhang, MD

  The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: March 7, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CN (2)