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

October 17, 2023 updated by: a2 Milk Company Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Keming Zhang, MD
  • Phone Number: +86 155 2221 1995
  • Email: zzkkmmxx@163.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: a2 Group
The group consuming a2Milk skim milk powder (1L) containing A2 β-casein only
Other: a2Milk skim milk powder
a2Milk skim milk powder (1L) containing A2 β-casein only
Other Names:
  • Treatment group
Placebo Comparator: Control Group
The group consuming Yili skim milk powder (1L) containing A1 and A2 β-caseins
Other: Yili skim milk powder
Yili skim milk powder (1L) containing A1 and A2 β-caseins
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
Visit 2 (14 days after baseline); Visit 4 (90 days after baseline); baseline (14 days after enrolment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
Changes of quality of life at Visit 4 compared to baseline
Time Frame: Visit 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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
a2 Milk Company Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
General Hospital of Tianjin Medical University
Edanz Group Japan Ltd
Beijing Esmile Technology Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keming Zhang, MD, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A2MC-G190549358

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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