UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038440 |
|---|---|
| Receipt number | R000043800 |
| Scientific Title | Case study about the effect of plant extract containing food on cognitive function |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/11/01 10:23:25 |
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Basic information
Public title
Case study about the effect of plant extract containing food on cognitive function
Acronym
Evaluation of the effect of plant extract containing food
Scientific Title
Case study about the effect of plant extract containing food on cognitive function
Scientific Title:Acronym
Evaluation of the effect of plant extract containing food
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 12-month continuous intake of the food containing plant extract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test (MMSE, Cognitrax)
Key secondary outcomes
Blood and urine test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of test food for 12 months
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who regularly visit a "Brain Care Clinic" and have a confirmed diagnosis of mild cognitive impairment
2) Those who have written consent from the subject himself / herself in writing
Key exclusion criteria
1) Those whose test results of cognitive function are too unstable and severe to determine the effect of the test food
2) Those who already use health supplements similar to the test food
3) Those who use health supplements and pharmaceuticals judged by the investigator that will affect the study
4) Those who are participating in other clinical trials at the start of this study, or who are within 3 months from other clinical trials to participation in this study
5) Those who may develop allergies by taking the test food
6) Those who have digestive system disease, or have undergone operation of digestive tract (except for appendicitis)
7) Patients with present or past history of abnormal glucose metabolism, abnormal lipid metabolism, liver disease, kidney disease, cardiovascular disease, endocrine disease, digestive system disease, immune system disease, and mental illness
8) Those who are judged to be inappropriate as test subjects from laboratory tests and blood pressure measurements
9) Those who wish to become pregnant during the study period, or who are currently pregnant or breastfeeding
10) Any other person judged by the investigator as inappropriate
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Konno |
Organization
Brain Care Clinic
Division name
honorary director
Zip code
160-0017
Address
Isobe Building 2F, 13, Samon, Shinjuku-ku, Tokyo
TEL
03-3351-3386
info@brain-care.jp
Public contact
Name of contact person
| 1st name | Norimasa |
| Middle name | |
| Last name | Kobayashi |
Organization
FUJI-SANGYO CO.,LTD
Division name
Research and Development Laboratory
Zip code
763-0071
Address
1301, Tamura, Marugame, Kagawa, Japan
TEL
0877-25-3221
Homepage URL
kobayashi@fuji-sangyo.co.jp
Sponsor or person
Institute
FUJI-SANGYO CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
FUJI-SANGYO CO.,LTD
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
Brain Care Clinic Ethics Review Committee
Address
Isobe Building 2F, 13, Samon, Shinjuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | 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
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043800
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
