UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033581 |
|---|---|
| Receipt number | R000038293 |
| Scientific Title | Effects of odor components generated by the Maillard reaction in foods on human physiology and improvement of task performance -controlled and uncontrolled studies on miosis rate, fingertip temperature, fatigue level of brain, oxyhemoglobin level of brain, stress marker level, and performance of a simple task- |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/04/02 14:44:16 |
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Basic information
Public title
Effects of odor components generated by the Maillard reaction in foods on human physiology and improvement of task performance -controlled and uncontrolled studies on miosis rate, fingertip temperature, fatigue level of brain, oxyhemoglobin level of brain, stress marker level, and performance of a simple task-
Acronym
Effects of odor components generated by the Maillard reaction in foods on human physiology and improvement of task performance
Scientific Title
Effects of odor components generated by the Maillard reaction in foods on human physiology and improvement of task performance -controlled and uncontrolled studies on miosis rate, fingertip temperature, fatigue level of brain, oxyhemoglobin level of brain, stress marker level, and performance of a simple task-
Scientific Title:Acronym
Effects of odor components generated by the Maillard reaction in foods on human physiology and improvement of task performance
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of odor components from the Maillard reaction in foods on physiological function and performance of a task
Basic objectives2
Others
Basic objectives -Others
effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic nerve activity, blood flow rate of brain, and level of task performance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Smelling of 2,5-dimethyl-4-hydroxy-3(2H)-furanone (58ppm) for 2 min. Measurement of miosis rate, fingertip temperature, fatigue level of brain, oxyhemoglobin level of brain, stress marker level, and performance of a simple task for 2 min.
Interventions/Control_2
Smelling of 2,3-, 2,5-, or 2,6-dimethylpyrazine (0.9ppm) for 2 min. Measurement of miosis rate, fingertip temperature, fatigue level of brain, oxyhemoglobin level of brain, stress marker level, and performance of a simple task for 2 min.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy
Key exclusion criteria
otolaryngology disorder, psychiatric disorder, epidemic cold, cigarette smoker, epilepsy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Ohata |
Organization
Nihon University
Division name
College of Bioresource Science
Zip code
252-0880
Address
1866, Kameino, Fujisawa, Kanagawa, Japan
TEL
0466-84-3987
oohata.motoko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Ohata |
Organization
Nihon University
Division name
College of Bioresource Science
Zip code
252-0880
Address
1866, Kameino, Fujisawa, Kanagawa, Japan
TEL
0466-84-3987
Homepage URL
oohata.motoko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3, Hongo, Bunkyo, Tokyo, Japan
Tel
03-5802-1589
kenkyu5858@juntendo.ac.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
| 2018 | Year | 08 | Month | 01 | 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
120
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038293
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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