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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026733
Receipt No. R000030689
Scientific Title Objevtive anti-stress evaluation of gum chewing and histidine intake
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/28

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Basic information
Public title Objevtive anti-stress evaluation of gum chewing and histidine intake
Acronym Chewing and histidine
Scientific Title Objevtive anti-stress evaluation of gum chewing and histidine intake
Scientific Title:Acronym Chewing and histidine
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of anti-stress of gum chewing and histidine intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Autonomic function
Key secondary outcomes Anthropometry (Height, Weight, Body fat percentage), Blood pressure, Masticatory strength, Food intake, Stress marker in saliva

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Stress (10 min)



Interventions/Control_2 Stress (10 min) + gum chewing (10 min)
Interventions/Control_3 Stress (10 min) + histidine (0.33 g/ 1 time*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
24 years-old >=
Gender Female
Key inclusion criteria Obtained written informed consent from the women before the participation
Key exclusion criteria Those who felt this study was inconvenient to everyday life.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiko Kuwano
Organization The university of shizuoka
Division name School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL 054-264-5513
Email kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiko Kuwano
Organization The university of shizuoka
Division name School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL 054-264-5513
Homepage URL
Email kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute The university of shizuoka
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 04 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
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
2016 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030689

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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