Study of the effects of the food containing plant-derived ingredient on brain function and its associated symptoms -A randomized, double-blind, placebo-controlled, crossover study-

Study of the effects of the food containing plant-derived ingredient on brain function and its associated symptoms -A randomized, double-blind, placebo-controlled, crossover study- - Effects of plant-derived ingredient on brain function.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029163

Enrollment

Registered

2017-09-15

Start date

2017-09-15

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 (MCI) and mild dementia.

Interventions

Intake of beverage containing plant-derived ingredient (active beverage), twice a day, for 12 weeks. -Washout for 4 weeks. -Intake of beverage without plant-derived ingredient (placebo beverage), twic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) MCI or mild dementia patients who are between 60 and 85 years old at the time of registration. 2) Subjects who shows 23 or more scores in MMSE. 3) Subjects who haven't taken treatment for cancer, myocardial infarction, or stroke within the past 5 years. 4) Subjects who do not take drugs used to treat dementia (Aricept, Reminyl, Rivastach, Memary) 5) Subjects who are not depressed with the GDS scores of less than 5. 6) Subjects who can visit the clinic on appointed days. 7) Subjects who can fully understand the purpose and contents of this study, and voluntarily agree to participate in this study with written consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who have food allergy. 2) Subjects who underwent surgery for cerebrovascular disease. 3) Subjects who take medicine that may influence the outcome of this study (e.g., antipsychotic drug). 4) Subjects who take supplement or food that may influence the outcome of this study (e.g., food for specified health uses). 5) Subjects who experienced unpleasant feeling during blood collection. 6) Subjects who have participated in other clinical study within the last 4 weeks. 7) Heavy drinker and smoker. 8) Subjects who have extremely irregular dietary pattern. 9) Subjects who don't agree to the purpose and contents of this study. 10) Subjects who drink more than two or more cups of coffee daily. 11) Subjects who are judged unsuitable for participating in this study by doctors.

Design outcomes

Primary

Measure	Time frame
Neuropsychological tests before and after the 12-week treatment period (MMSE, ADAS-cog, Trail Making Test and CDR)	—

Secondary

Measure	Time frame
Epworth sleepiness scale, blood analyses, questionnaires	—

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales Department

yoshi@kso.co.jp+81-3-3452-7733

Outcome results

None listed

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