UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035289 |
|---|---|
| Receipt number | R000040203 |
| Scientific Title | Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion |
| Date of disclosure of the study information | 2018/12/24 |
| Last modified on | 2021/03/28 04:53:00 |
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Basic information
Public title
Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion
Acronym
Validation of preferred salt concentration as soup for health promotion
Scientific Title
Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion
Scientific Title:Acronym
Validation of preferred salt concentration as soup for health promotion
Region
| Japan |
Condition
Condition
adults
Classification by specialty
| Not applicable | 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, and to explore the preferred salt concentration as soup which contribute to improvement of food environment for health promotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Salty taste and palatability by sensory evaluation
Key secondary outcomes
Reduction of sodium intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
| Not applicable |
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 cognitive impairment
(2) persons who were judged inadequate by investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Hayabuchi |
Organization
Nara Women's University
Division name
Faculty of human life and environment, Department of food science and nutrition
Zip code
830-8506
Address
Kita-uoya Nishi-machi, Nara-city, Nara, Japan.
TEL
0742-20-3488
h.hayabuchi@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Hayabuchi |
Organization
Nara Women's University
Division name
Faculty of human life and environment, Department of food science and nutrition
Zip code
830-8506
Address
Kita-uoya Nishi-machi, Nara-city, Nara, Japan.
TEL
0742-20-3488
Homepage URL
h.hayabuchi@cc.nara-wu.ac.jp
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
Funding Source
Organization
Institute for Inovation, Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Inovation, Ajinomoto Co., Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee at Nara Women's University
Address
Kita-uoya Higashi-machi, Nara-city, Nara, Japan
Tel
0742-20-3762
kenkyou@cc.nara-wu.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
奈良女子大学(奈良県)、福岡女子大学(福岡県)、東北大学(宮城県)、琉球大学(沖縄県)、製鉄記念八幡病院(福岡県)、JA静岡厚生連遠州病院(静岡県)、日下医院(広島県)、JMA東埼玉総合病院(埼玉県)
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
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040203
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/06/21 | 実施計画書_18早渕.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/06/21 | 汁物調査データ_18仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/06/21 | 汁物調査データ抜粋＿18研究症例データ.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/40203
