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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033581
Receipt No. 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 2019/08/01

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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
Email 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
Email oohata.motoko@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

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
Email 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 No longer recruiting
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
2020 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
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038293

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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