Mild Cognitive ImpairmentNCT05741047
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
A study testing a2Milk skim milk powder and Yili skim milk powder in people with Mild Cognitive Impairment and Adults, run by a2 Milk Company Ltd. at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment, Adults
- What is being tested?
- a2Milk skim milk powder and Yili skim milk powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesChina
- Study dates
- 7 Mar 2023to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
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 education
- Living 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 consent
Participants must be excluded from the study if they meet any of the following criteria:
- <65 years; or >75 years
- 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;
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
General Hospital of Tianjin Medical University
Tianjin
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
About this study
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
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
- Being tested
- a2Milk skim milk powder, Yili skim milk powder
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a2Milk skim milk powderOther
Also called Treatment group
a2Milk skim milk powder (1L) containing A2 β-casein only
Yili skim milk powderOther
Also called Control group
Yili skim milk powder (1L) containing A1 and A2 β-caseins
| Study group | Role | What they receive |
|---|---|---|
| a2 Group | Active comparator | The group consuming a2Milk skim milk powder (1L) containing A2 β-casein only Receives: Other: a2Milk skim milk powder |
| Control Group | Placebo comparator | The group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins Receives: Other: Yili skim milk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Record short-chain fatty acids (mg/g) as a faecal marker of inflammation
Measured: 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
Record Healthy Brain Ageing - Functional Assessment Questionnaire via patient self-report as a quality of life measure
Measured: Visit 4 (90 days after baseline); baseline (14 days after enrolment)
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
Measured: Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start7 Mar 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- a2 Milk Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Edanz Group Japan Ltd, Beijing Esmile Technology Co. Ltd., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
- Investigators
- Keming Zhang, MD, Principal investigator, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741047
- Sponsor's protocol ID
- A2MC-G190549358
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40373392
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05741047
- Acronym / sponsor ID
- A2MC-G190549358
- Conditions
- Mild Cognitive Impairment, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- a2 Milk Company Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Edanz Group Japan Ltd, Beijing Esmile Technology Co. Ltd., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Medical University General Hospital
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a2 Group | Active comparator | Other: a2Milk skim milk powderThe group consuming a2Milk skim milk powder (1L) containing A2 β-casein only |
| Control Group | Placebo comparator | Other: Yili skim milk powderThe group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a2Milk skim milk powderAlso: Treatment groupa2Milk skim milk powder (1L) containing A2 β-casein only | Other | a2 Group |
| Yili skim milk powderAlso: Control groupYili skim milk powder (1L) containing A1 and A2 β-caseins | Other | Control Group |
Primary outcome
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline
Time frame: Visit 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 baseline
Time frame: Visit 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
3 secondary outcomes
Changes of short-chain fatty acids at Visit 2, 3, and 4 compared to baseline
Time frame: 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
Time frame: Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Changes of C-reactive protein at Visit 2 and 4 compared to baseline
Time frame: Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 40373392Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keming Zhang, MD principal investigator
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a2Milk skim milk powder and Yili skim milk powder in people with Mild Cognitive Impairment and Adults, run by a2 Milk Company Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline (time frame: Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.