UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029163 |
|---|---|
| Receipt number | 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 | 2020/03/04 16:22:56 |
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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 | 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
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
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033345
