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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020514
Receipt No. R000023682
Scientific Title Umami seasonings with a low sodium diet alleviates the stress of subjects
Date of disclosure of the study information 2016/01/09
Last modified on 2016/01/09

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Basic information
Public title Umami seasonings with a low sodium diet alleviates the stress of subjects
Acronym Umami seasonings with a low sodium diet alleviates the stress of subjects
Scientific Title Umami seasonings with a low sodium diet alleviates the stress of subjects
Scientific Title:Acronym Umami seasonings with a low sodium diet alleviates the stress of subjects
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure mood and phsychological stress during administration of a low sodium diet with and without MSG supplementation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MSG seasoning with a low sodium diet in 10 days coud alleviates the stress
Key secondary outcomes Mood state was not changed during the intervention of 10 days

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Low sodium diet with MSG supplementation (10 days)
Interventions/Control_2 Control: Low sodium diet without MSG supplementation (10 days)
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
35 years-old >=
Gender Female
Key inclusion criteria Obtained written informed consent from the women before the participation
Key exclusion criteria Without food allergies or taking medicine
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamami Iwamoto
Organization Jumonji University
Division name Department of Food and Nutrition, Faculty of Human Life
Zip code
Address 2-1-28 Sugasawa Niza-shi Saitama-Ken
TEL 048-477-0555
Email iwamoto@jumonji-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamami Iwamoto
Organization Jumonji University
Division name Department of Food and Nutrition, Faculty of Human Life
Zip code
Address 2-1-28 Sugasawa Niza-shi Saitama-Ken
TEL 048-477-0555
Homepage URL
Email iwamoto@jumonji-u.ac.jp

Sponsor
Institute Jumonji University
Institute
Department

Funding Source
Organization Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 01 Month 09 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
2012 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 10 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
2016 Year 01 Month 09 Day
Last modified on
2016 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023682

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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