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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200041
Enrollment
80
Registered
2020-09-02
Start date
2020-09-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment Mild cognitive impairment

Interventions

Take tablets containing b-lactoline or placebo once a day for 24 weeks
Cognitive function

Sponsors

Muto Shigeki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Cognitive function assessments (MMSE-J, MoCA-J)

Secondary

MeasureTime frame
Cognitive function assessments, mental funciton assessments, QOL assessments

Contacts

Public ContactTakayuk Ikeda

Seirei Medical Checkup Center

t-ikeda@sis.seirei.or.jp+81-53-439-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026