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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038440
Receipt No. 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 2019/10/30

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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
Email 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
Email kobayashi@fuji-sangyo.co.jp

Sponsor
Institute FUJI-SANGYO CO.,LTD
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 30 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043800

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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