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

Not Applicable

Completed

• Conditions: Adults; Mild Cognitive Impairment

• Registration Number: NCT05741047
• Lead Sponsor: a2 Milk Company Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-03-07
• Status Verified: 2023-10
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of Subtle Cognitive Impairment Test (SCIT) at Visit 2 and Visit 4 compared to baseline	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	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 Outcome Measures

Name	Time	Method
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)	Record C-reactive protein (mg/L) as a blood marker of inflammation
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)	Record short-chain fatty acids (mg/g) as a faecal marker of inflammation
Changes of quality of life at Visit 4 compared to baseline	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

Trial Locations

Locations (2)

General Hospital of Tianjin Medical University; 🇨🇳 Tianjin, China

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; 🇨🇳 Tianjin, China