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

Primary Purpose

Mild Cognitive Impairment, Adults

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
a2Milk skim milk powder
Yili skim milk powder
Sponsored by
a2 Milk Company Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Tianjin Medical University
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

a2 Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
February 14, 2023
Last Updated
October 17, 2023
Sponsor
a2 Milk Company Ltd.
Collaborators
Edanz Group Japan Ltd, Beijing Esmile Technology Co. Ltd., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, General Hospital of Tianjin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05741047
Brief Title
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
October 13, 2023 (Actual)
Study Completion Date
October 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
a2 Milk Company Ltd.
Collaborators
Edanz Group Japan Ltd, Beijing Esmile Technology Co. Ltd., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, General Hospital of Tianjin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a2 Group
Arm Type
Active Comparator
Arm Description
The group consuming a2Milk skim milk powder (1L) containing A2 β-casein only
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins
Intervention Type
Other
Intervention Name(s)
a2Milk skim milk powder
Other Intervention Name(s)
Treatment group
Intervention Description
a2Milk skim milk powder (1L) containing A2 β-casein only
Intervention Type
Other
Intervention Name(s)
Yili skim milk powder
Other Intervention Name(s)
Control group
Intervention Description
Yili skim milk powder (1L) containing A1 and A2 β-caseins
Primary Outcome Measure Information:
Title
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline
Description
Record responding time and speed on the SCIT test
Time Frame
Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Title
Changes of serum glutathione (GSH) at Visit 2 and Visit 4 compared to baseline
Description
Record serum glutathione (GSH) (µmol/L) as an anti-oxidation marker
Time Frame
Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Secondary Outcome Measure Information:
Title
Changes of short-chain fatty acids at Visit 2, 3, and 4 compared to baseline
Description
Record short-chain fatty acids (mg/g) as a faecal marker of inflammation
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)
Title
Changes of quality of life at Visit 4 compared to baseline
Description
Record Healthy Brain Ageing - Functional Assessment Questionnaire via patient self-report as a quality of life measure
Time Frame
Visit 4 (90 days after baseline); baseline (14 days after enrolment)
Title
Changes of C-reactive protein at Visit 2 and 4 compared to baseline
Description
Record C-reactive protein (mg/L) as a blood marker of inflammation
Time Frame
Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keming Zhang, MD
Organizational Affiliation
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
Country
China

12. IPD Sharing Statement

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

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