UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041423
Receipt number R000047272
Scientific Title Survey Research 2 of Indicators Relating to the Activity of the Brain Based on Functionality of Food(Taxifolin)
Date of disclosure of the study information 2020/08/15
Last modified on 2022/01/30 21:29:59

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Basic information

Public title

Survey Research 2 of Indicators Relating to the Activity of the Brain Based on Functionality of Food(Taxifolin)

Acronym

Survey Research 2 of Indicators Relating to the Activity of the Brain Based on Functionality of Food(Taxifolin)

Scientific Title

Survey Research 2 of Indicators Relating to the Activity of the Brain Based on Functionality of Food(Taxifolin)

Scientific Title:Acronym

Survey Research 2 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.Person participated in the previous "Survey Research of Indicators Relating to the Activity of the Brain Based on Functionality of Food(Taxifolin)"(19R-082)and carried out brain function-related index evaluation test CDB within 3 months before the start of this study 2.Person who has a disorder that is an obstacle to this study 3.The person in charge of research, Professor Yasuhiro Nishizaki, will be the person in charge of the course, in order not to affect the evaluation of academic work 4.Others who are deemed inappropriate by the research leader or co-worker

Target sample size

30


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 or person

Institute

Tokai University

Institute

Department

Personal name



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

2020 Year 08 Month 15 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

2020 Year 05 Month 15 Day

Date of IRB

2020 Year 06 Month 17 Day

Anticipated trial start date

2020 Year 08 Month 20 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 04 Month 05 Day

Date trial data considered complete

2021 Year 04 Month 05 Day

Date analysis concluded

2021 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 15 Day

Last modified on

2022 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name