UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054283 |
|---|---|
| Receipt number | R000061990 |
| Scientific Title | Study of salt intake from noodles |
| Date of disclosure of the study information | 2024/04/29 |
| Last modified on | 2025/04/23 11:24:31 |
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Basic information
Public title
Study of salt intake from noodles
Acronym
Study of salt intake from noodles
Scientific Title
Study of salt intake from noodles
Scientific Title:Acronym
Study of salt intake from noodles
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the salt-reducing effects of the nutritional dietary guidance "Let's leave the soup" when eating noodles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salt intake
Key secondary outcomes
Soup and salt intake per mouthful
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Free eating - (washout period) - Leave the soup
Interventions/Control_2
Leave the soup - (washout period) - Free eating
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
| 23 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Healthy female university students
2) Subjects who have received a sufficient explanation of the purpose and content of this study, and agreed to participate by signing
Key exclusion criteria
1) Subjects with abnormal blood pressure and renal function
2) Subjects with diseases that require constant medication
3) Subjects with medical history of severe diseases
4) Subjects who are judged as inappropriate by investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya Aoi University
Division name
Faculty of Health Sciences Department of Health and Nutrition
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-852-9422
nishida@nagoya-aoi.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya Aoi University
Division name
Faculty of Health Sciences Department of Health and Nutrition
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528529422
Homepage URL
nishida@nagoya-aoi.ac.jp
Sponsor or person
Institute
Nagoya Aoi University
Institute
Department
Personal name
Funding Source
Organization
Nagoya Aoi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Research on Human Subjects in Nagoya Women's University
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-852-1111
somu@nagoya-aoi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-17
Org. issuing International ID_1
Ethics Review Committee for Research on Human Subjects in Nagoya Women's University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 29 | 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
10
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
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061990
