UMIN-CTR Clinical Trial

Basic information
Public title	Survey Research of Indicators Relating to the Activity of the Brain Based on Functionality of Food (Taxifolin)
Acronym	Survey Research of Indicators Relating to the Activity of the Brain Based on Functionality of Food (Taxifolin)
Scientific Title	Survey Research of Indicators Relating to the Activity of the Brain Based on Functionality of Food (Taxifolin)
Scientific Title:Acronym	Survey Research of Indicators Relating to the Activity of the Brain Based on Functionality of Food (Taxifolin)
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare and evaluate brain function related indicators useful for evaluating the functionality of food.
Basic objectives2	Others
Basic objectives -Others	Investigation of indicators related to brain function
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	No decision
Key secondary outcomes	No decision

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	YES
Dynamic allocation	YES
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	6 taxifolin-added tablets-Washout period-6 taxifolin-free tablets
Interventions/Control_2	6 taxifolin-free tablets-Washout period-6 taxifolin-added tablets
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	29 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy volunteer 2. Males and females aged between 20 and 29 3. Person who receive adequate explanation for participation in this research and provide written informed consent by their own free will
Key exclusion criteria	1. A person who participated in the previous "An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa)" (18R020) or "An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food" (19R016)and carried out brain function-related index evaluation test CDB (Cognitive Demand Battery) 2. Person who has a disorder that is an obstacle to this study 3. Others who are deemed inappropriate by the research leader or co-worker
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Nishizaki
Organization	Tokai University School of Medicine
Division name	Department of Clinical Health Science
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL	0463-93-1121
Email	y-nishizaki@tokai.ac.jp

Public contact
Name of contact person	1st name Takashige Middle name Last name Oroguchi
Organization	Tokai University School of Medicine
Division name	Lifecare Center Graduate School of Medicine
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL	0463-93-1121
Homepage URL
Email	oroguchi@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board for Clinical Research, Tokai University Hospital
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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	東海大学医学部大学院医学研究科ライフケアセンター(神奈川)

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 07 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 08 Month 15 Day
Date of IRB	2019 Year 09 Month 17 Day
Anticipated trial start date	2019 Year 10 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 04 Month 15 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 07 Day
Last modified on	2020 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043565