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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029163
Receipt No. R000033345
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-
Date of disclosure of the study information 2017/09/15
Last modified on 2019/01/30

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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
Middle name
Last name Takashi Asada
Organization Memory Clinic Ochanomizu
Division name Chief director
Zip code
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
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales Department
Zip code
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
Address
Tel
Email

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
2019 Year 01 Month 30 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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