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
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
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
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
