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Completed

NCT Number: NCT05741047

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

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Tianjin Medical University, Tianjin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a2Milk skim milk powder

Other

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

Other names: Treatment group

Yili skim milk powder

Other

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

Other names: Control group

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

a2 Milk Company Ltd.

Industry

Collaborators

  • Beijing Esmile Technology Co. Ltd.
  • Edanz Group Japan Ltd
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Tianjin Medical University General Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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