UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043800