UMIN-CTR Clinical Trial

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
Institute	RIKEN
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050907