UMIN-CTR Clinical Trial

Basic information
Public title	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-
Acronym	Effects of plant-derived ingredient on brain function.
Scientific Title	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-
Scientific Title:Acronym	Effects of plant-derived ingredient on brain function.
Region	Japan

Condition
Condition	Mild cognitive impairment (MCI) and mild dementia.
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effects of the plant-derived ingredient on brain function and its associated symptoms in MCI and dementia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neuropsychological tests before and after the 12-week treatment period (MMSE, ADAS-cog, Trail Making Test and CDR)
Key secondary outcomes	Epworth sleepiness scale, blood analyses, questionnaires

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	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), twice a day, for 12 weeks.
Interventions/Control_2	Intake of placebo beverage, twice a day, for 12 weeks. -Washout for 4 weeks. -Intake of active beverage, twice a day, for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Asada
Organization	Memory Clinic Ochanomizu
Division name	Chief director
Zip code	113-0034
Address	1-5-34, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-6801-8718
Email	asada@memory-cl.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales Department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	+81-3-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinagawa Season Terrace Health Care Clinic
Address	Minato-ku, Tokyo, Japan
Tel	03-3452-3381
Email	tomohiro_kogo@sempos.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団　創知会 メモリークリニックお茶の水

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 09 Month 03 Day
Date analysis concluded	2018 Year 09 Month 27 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 15 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033345