UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058335 |
|---|---|
| Receipt number | R000066690 |
| Scientific Title | Study on the Effect of Cooking Activities Using Specific Ingredients on Oxytocin Secretion - Single-Group Pre-Post Comparison Trial (Open-Label Trial) - |
| Date of disclosure of the study information | 2025/07/02 |
| Last modified on | 2025/07/01 16:46:49 |
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Basic information
Public title
Study of the impact of parent-child cooking on "bonding hormones"
Acronym
Study of the impact of parent-child cooking on "bonding hormones"
Scientific Title
Study on the Effect of Cooking Activities Using Specific Ingredients on Oxytocin Secretion - Single-Group Pre-Post Comparison Trial (Open-Label Trial) -
Scientific Title:Acronym
Study on the Effect of Cooking Activities Using Specific Ingredients on Oxytocin Secretion - Single-Group Pre-Post Comparison Trial (Open-Label Trial) -
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impacts of co-cooking activities with parents (especially the involvement of children in their work with specific ingredients on their offspring's salivary oxytocin levels) among primary school children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin concentration
Key secondary outcomes
Subjective evaluation of cooking activities
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Cooking activities for hot dogs that use specific foods for topping are conducted under the guidance and assistance of research staff.
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Elementary school-age boys and girls aged 6 to 12 years or younger
2. Persons who have given written informed consent to participate in the study after having received adequate explanation and understanding of the content of the study by their parents.
3. Subjects who understood the research content and gave consent to participate in the study (acent)
4. Persons who can visit the designated research site on the day of the study
Key exclusion criteria
1.People who have a food allergy to foodstuffs (eggs, wheat, soybeans, etc.) used in this study as diagnosed by a physician
2.Persons with a history of diagnosis or treatment of serious heart disease, endocrine disease, mental disease, etc.
3.Persons who are taking drugs that may affect hormone secretion on a regular basis.
4.Other than the above, the person who is judged by the research director as an inappropriate research subject.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Fujiwara |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo, Japan
TEL
0353847759
naoki_fujiwara@kewpie.co.jp
Public contact
Name of contact person
| 1st name | YUI/WEI |
| Middle name | |
| Last name | OU/WANG |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo, Japan
TEL
0353847759
Homepage URL
yui_ou@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
Shiba Palace Clinic Ethics Committee
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2025 | Year | 07 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066690
