The effects of b-lactolin on cognitive function for mild cognitive decline -A randomized double-blind placebo controlled trial-

JRCT ID: jRCTs041200041

Registered date:02/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild cognitive impairment
• Date of first enrollment: 02/09/2020
• Target sample size: 80
• Study type: Interventional

Intervention(s)

<Ingestion of research food>
Take tablets containing b-lactoline or placebo once a day for 24 weeks

Outcome(s)

• Primary Outcome: Cognitive function assessments (MMSE-J, MoCA-J)
• Secondary Outcome: Cognitive function assessments, mental funciton assessments, QOL assessments

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age: Men and women 50 years or older when consent is obtained
2) MMSE-J score at pre-examination: Those with a score of 24 to 28
3) CDR (memory and orientation) at pre-examination: Those with a score of 0.5
4) Those who, after receiving a sufficient explanation before participating in this research, have a sufficient understanding and have obtained the informed consent of the research subject.

Exclude criteria

1) Those who are currently undergoing treatment or follow-up for diseases (Epilepsy, stroke, dementia,Parkinson's disease, etc.) of the cranial nervous system
2) GDS score at pre-examination: Those with a score of 10 or more
3) Those who may have allergies to the raw material (milk) of research food
4) Those who is pregnant or going to be pregnant (female)
5) Those who cannot take MRI, such as pacemakers,body metal such as brain clips and bolts, tattoos (including tattoos and permanent makeup), etc.
6) Those who have difficulty distinguishing colors
7) Those who have participated in other clinical trials within 1 month before the pre-examination or who plan to participate in other clinical studies during this research period
8) Those who regularly drink more than properdrinking (about 20 g of alcohol per day: about 500mL of beer, about 180 mL of wine, about 180 mL ofsake, about 60 mL of whiskey double)
9) Those who have smoking habits
10) Those who continuously take supplements containing high amounts of protein (high protein supplements) for the purpose of strengthening muscle once a week or more
11) Those who have difficulty in taking research food (8 mm diameter tablets, 5 tablets per dose)
12) Those who are judged to be inappropriate by the investigator

Related Information

• Primary Sponsor: Muto Shigeki
• Source(s) of Monetary Support: Kirin Holdings Company, Limited