UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052989 |
|---|---|
| Receipt number | R000060452 |
| Scientific Title | Effect of research food consumption on Nasal Discomforts |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/04 14:33:17 |
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Basic information
Public title
Effect of research food consumption on Nasal Discomforts
Acronym
Effect of research food consumption on Nasal Discomforts
Scientific Title
Effect of research food consumption on Nasal Discomforts
Scientific Title:Acronym
Effect of research food consumption on Nasal Discomforts
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to effects of consuming the study foods on those with nasal discomfort by comparing them to the non-treatment group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nasal discomfort
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ingestion of test foods (research foods)
Interventions/Control_2
No treatment
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese over 12 years old
(2) If over 18 years of age and with sufficient capacity to make decisions, those who can obtain the individual's consent
(3) If under 18 years of age, those with parental consent
(4) Subjects who related to Shizuoka Prefecture sports club teams
(5) Subjects who have nasal discomfort during the period from February to April
(6) Subjects who able to maintain a consistent daily lifestyle during the study period.
Key exclusion criteria
(1) Subjects who are currently receiving medication for some disease.
(2) Subjects with serious diseases (diabetes, heart disease, cancer, etc.) or mental illness.
(3) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past.
(4) Subjects receiving desensitization therapy
(5) Subjects with possible food or drug allergies to the test foods.
(6) Subjects who are otherwise ineligible for participation in this study by the investigater.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Mastuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_mastuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Fumika |
| Middle name | |
| Last name | Kamijo |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
fumika_kamijo@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2023 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | 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
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
