UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035280 |
|---|---|
| Receipt number | R000040195 |
| Scientific Title | Validation of preferred salt concentration as soup in young adults |
| Date of disclosure of the study information | 2018/12/24 |
| Last modified on | 2019/06/17 11:55:40 |
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Basic information
Public title
Validation of preferred salt concentration as soup in young adults
Acronym
Validation of preferred salt concentration as soup in young adults
Scientific Title
Validation of preferred salt concentration as soup in young adults
Scientific Title:Acronym
Validation of preferred salt concentration as soup in young adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the influence of Umami on the salty tast or palatability of low salt solution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Taste (salty taste, palatability)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
0.3 % NaCl aqueous solution (w/v)
Interventions/Control_2
0.3 % NaCl + 0.3 % glutamate Na aqueous solution (w/v)
Interventions/Control_3
0.6 % NaCl aqueous solution (w/v)
Interventions/Control_4
0.6 % NaCl + 0.3 % glutamate Na aqueous solution (w/v)
Interventions/Control_5
0.9 % NaCl aqueous solution (w/v)
Interventions/Control_6
0.9 % NaCl + 0.3 % glutamate Na aqueous solution (w/v)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult men and women who agreed to participate in this research with written informed consent.
Key exclusion criteria
(1) Persons with eating disorders.
(2) Persons with taste disorders.
(3) Persons who has eaten within 2 hours.
(4) Persons who judged that a principal investigator is inappropriate for participating in the examination.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Hayabuchi |
Organization
Fukuoka Women's University
Division name
Department of Food and Health Sciences, International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL
092-661-2411
s-hayabuchi@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Koga |
Organization
Fukuoka Women's University
Division name
Department of Food and Health Sciences, International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL
092-661-2411
Homepage URL
keiei@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ajinomoto co., Inc
Name of secondary funder(s)
Ajinomoto co., Inc
IRB Contact (For public release)
Organization
Research Ethics Review Committee at Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
Tel
092-661-2411
keiei@fwu.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
福岡女子大学(福岡県)、青森県立保健大学(青森県)、千葉県立保健医療大学(千葉県)、相模女子大学(神奈川県)、静岡県立大学(静岡県)、安田女子大学(広島県)、鹿児島純心女子大学(鹿児島県)、奈良女子大学(奈良県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040195
