UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020514 |
|---|---|
| Receipt number | 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 16:04:18 |
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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
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
iwamoto@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023682
