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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042623
Receipt No. R000048640
Scientific Title Cognitive function improvement effect by FJ-319 compounded food : a randomized, double-blind, placebo-controlled, cross-over trial.
Date of disclosure of the study information 2020/12/03
Last modified on 2021/05/26

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Basic information
Public title Cognitive function improvement effect by FJ-319 compounded food
Acronym FJ Cognitive function study
Scientific Title Cognitive function improvement effect by FJ-319 compounded food : a randomized, double-blind, placebo-controlled, cross-over trial.
Scientific Title:Acronym Cognitive function improvement effect by FJ-319 compounded food
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing and evaluating changes in cognitive function after a single ingestion of the test article
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes WMS-R
Key secondary outcomes TMT-J, LFT

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 first trial ; Intake test article
second trial ; Intake placebo
Interventions/Control_2 first trial ; Intake placebo
second trial ; Intake test article
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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who do not have dementia but are aware of age-related decline in cognitive function
Key exclusion criteria 1. Subjects who are judged to have dementia, those who are receiving treatment, medication, and lifestyle guidance from a doctor due to dementia, those who have received it in the past
2. Subjects with serious cerebrovascular disease, heart disease, liver disease, kidney disease, digestive system disease, infectious diseases that require notification, etc.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan clinical trial assosiation
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan clinical trial assosiation
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial assosiation
Institute
Department

Funding Source
Organization FUJISANGYO 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 Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2020 Year 12 Month 03 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 35
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
2020 Year 09 Month 25 Day
Date of IRB
2020 Year 10 Month 15 Day
Anticipated trial start date
2020 Year 12 Month 16 Day
Last follow-up date
2021 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 02 Day
Last modified on
2021 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048640

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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