UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035658 |
|---|---|
| Receipt number | R000040592 |
| Scientific Title | A study to evaluate the preventive effect of Matcha tea on decline in cognitive function and decline in daily living activity. |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2021/11/30 09:30:06 |
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Basic information
Public title
A study to evaluate the preventive effect of Matcha tea on decline in cognitive function and decline in daily living activity.
Acronym
A study to evaluate the preventive effect of Matcha tea on decline in cognitive function and decline in daily living activity.
Scientific Title
A study to evaluate the preventive effect of Matcha tea on decline in cognitive function and decline in daily living activity.
Scientific Title:Acronym
A study to evaluate the preventive effect of Matcha tea on decline in cognitive function and decline in daily living activity.
Region
| Japan |
Condition
Condition
Mild cognitive impairment (MCI)
Pre-MCI
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the preventive effect of Matcha tea on the decline in cognitive function and decline in daily living activity of elderly people with MCI as a pre-stage of dementia and pre-MCI in preclinical stage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Neuropsychological test (MoCA-J) and activities of daily living scale (ADCS-MCI-ADL) before ingestion, and after ingestion of Matcha tea or placebo for 6 months and for 12 months.
Key secondary outcomes
Neuropsychological test (MMSE-J, RBANS, ADAS-Jcog, Cognitrax)
The Pittsburgh Sleep Quality Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest of powdered Matcha capsules, 9 capsules a day, for 12 months.
Interventions/Control_2
Ingest of placebo capsules, 9 capsules a day, for 12 months.
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) Male and female between 60 and 85 years old of MCI or pre-MCI who use Japanese language as their mother tongue.
2) Subjects who have not received treatment for cancer, myocardial infarction, or stroke within the past 5 years.
3) Subjects who do not take drugs to treat dementia (Aricept, Reminyl, Rivastach, Memary).
4) Subjects who do not have atrophy of dementia in MRI image.
5) Subjects who have not done interventions such as exercise intervention and cognitive function training as usually performed in day-care.
6) Subjects who can visit the clinic on appointed days.
7) The cooperation of the study partner can be obtained. Study partners are not changed as much as possible.
8) Subjects who consented to APOE genotype analysis.
9) Subjects who agreed with the purpose and contents of this exam, voluntarily volunteered to participate after fully understanding, and who agreed in writing
(Criteria for MCI)
Type1: Complaint of memory disturbance from the participant plus approval by the study partner
Type2: Memory disturbance approved by the study partner, without the subjective complaint of the participant
Note) Exclude cases when only the memory disturbance from the person himself/herself is complained and the study partner does not accept it.
(1) MMSE-J 24-30.
(2) Scores of Wechsler memory Scale-R logical memory II corrected for education, below the cut-off levels.
Education 0-7 years 6 or lower
Education 8-15 years 9 or lower
Education over 16 years 11or lower
(3) CDR 0.5
(Criteria for Pre-MCI)
Subjects who are out of MCI's Criteria who are not dementia and who meet the following criteria
(1) Have awareness of forgetfulness (subjective cognitive decline, SCD)
(2)MMSE-J 27-30, or a subject with either mild hippocampal atrophy by MRI examination or mild rCBF reduction by SPECT examination.
(3) CDR 0
Key exclusion criteria
1) Those diagnosed with dementia
2) Those diagnosed with Major depressive disorder (MDD)
3) MMSE-J 24>
4) Subjects who have food allergy (Matcha, green tea allergy).
5) Subjects who underwent surgery for cerebrovascular disease.
6) Subjects who take medicine that may influence the outcome of this study (e.g., antipsychotic drug).
7) Subjects who take foods with function claims that may influence the outcome of this study.
8) Subjects who experienced unpleasant feeling during blood collection.
9) Subjects who have participated in other clinical study within the last 4 weeks.
10) Subjects s who drink more than 7 cups of Matcha per week
11) Subjects who cause physical condition by ingesting caffeine
12) Alcoholism
13) Subjects who have had surgery on the upper gastrointestinal tract.
14) Subjects who are judged unsuitable for participating in this study by doctors.
15) Those who can not agree with the purpose of this test conducted in advance.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Meno |
Organization
MCBI Inc.
Division name
Research & Development Department
Zip code
305-0031
Address
3F, 3-15-15, Azuma, Tsukuba, Ibaraki, Japan
TEL
029-855-5071
k.meno@mcbi.co.jp
Public contact
Name of contact person
| 1st name | Kohji |
| Middle name | |
| Last name | Meno |
Organization
MCBI Inc.
Division name
Research & Development Department
Zip code
305-0031
Address
3F, 3-15-15, Azuma, Tsukuba, Ibaraki, Japan
TEL
029-855-5071
Homepage URL
k.meno@mcbi.co.jp
Sponsor or person
Institute
MCBI Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
ITO EN, Ltd.
Shimadzu Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki,Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.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
筑波大学附属病院 (茨城県)、医療法人社団創知会メモリークリニックとりで (茨城県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 24 | 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
99
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040592
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