UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044563
Receipt number R000050907
Scientific Title Effects of food material on subjective feelings
Date of disclosure of the study information 2021/06/16
Last modified on 2021/06/16 18:03:16

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Basic information

Public title

Effects of food material on subjective feelings

Acronym

Effects of food material on subjective feelings

Scientific Title

Effects of food material on subjective feelings

Scientific Title:Acronym

Effects of food material on subjective feelings

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of food material on subjective feelings

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subjective feelings measured by the KOKORO scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

Taking the test capsules once a day for 2 weeks

Interventions/Control_2

Taking the placebo capsules once a day for 2 weeks

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

1. Healthy individuals aged between 20 and 60 years
2. Persons who can give written informed consents.

Key exclusion criteria

1. Women who are planning pregnancy, currently pregnant, or lactating
2. Individuals visiting the hospital and/or were on medications for diseases
3. Smokers
4. Persons who are judged not suitable to participate in this trial by investigators

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yasuhisa
Middle name
Last name Tamura

Organization

RIKEN

Division name

Laboratory for Cellular Functional Imaging

Zip code

650-0047

Address

6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN

TEL

078-304-7160

Email

tamuray@riken.jp


Public contact

Name of contact person

1st name Yasuhisa
Middle name
Last name Tamura

Organization

RIKEN

Division name

Laboratory for Cellular Functional Imaging

Zip code

650-0047

Address

6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN

TEL

078-304-7160

Homepage URL


Email

tamuray@riken.jp


Sponsor or person

Institute

RIKEN

Institute

Department

Personal name



Funding Source

Organization

Cross-ministerial Strategic Innovation Promotion Program

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Second Committee of the RIKEN Center for Biosystems Dynamics Research

Address

2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN

Tel

078-306-3036

Email

kobe-ankan@cdb.riken.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

2021 Year 06 Month 16 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

39

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Application for Patent

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

2018 Year 07 Month 11 Day

Date of IRB

2018 Year 06 Month 19 Day

Anticipated trial start date

2018 Year 07 Month 20 Day

Last follow-up date

2018 Year 11 Month 11 Day

Date of closure to data entry

2018 Year 11 Month 12 Day

Date trial data considered complete


Date analysis concluded

2020 Year 11 Month 19 Day


Other

Other related information



Management information

Registered date

2021 Year 06 Month 16 Day

Last modified on

2021 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name