UMIN-ICDS Clinical Trial

Public title

Investigation of the impact of potato salad preparation on hormone secretion - A single-arm pre-post comparative study

Acronym

Study on Hormonal Responses to Children's Independent Cooking

Scientific Title

Investigation of the impact of potato salad preparation on hormone secretion - A single-arm pre-post comparative study

Scientific Title:Acronym

Hormonal Effects of Potato Salad Cooking

Region

Japan

Condition

Healthy children and their parents

Classification by specialty

Adult

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of cooking activities using potato salad on salivary oxytocin and cortisol concentrations in elementary school children (aged 6 to 12 years) and their parents. By focusing on parent-child interactions specifically, children's proactive cooking challenges and parents' supportive observation we will investigate whether this experience improves children's vegetable intake. Furthermore, the study seeks to clarify the impact of these activities on building a trusting parent child relationship.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Salivary oxytocin and cortisol concentrations (Evaluation time points: For children, two times in total: immediately before the start of cooking activities and 10 minutes after the end of the cooking process. For parents, three times in total: immediately before the start of the children's cooking activities, 10 minutes after the end of the cooking process, and 10 minutes after the end of the children's tasting.)

Key secondary outcomes

Questionnaire survey for parents (Evaluation time points: two times in total, before the start of the study and at the end of the study) Content: Evaluation of parents' satisfaction and mood (e.g., changes in mood and contribution to dining table satisfaction through the experience of observing their children proactively cooking and eating), qualitative evaluation of children's behavior, etc.
Questionnaire survey for children (Evaluation time point: once at the end of the study) Content: Subjective evaluations such as enjoyment and sense of accomplishment in the cooking process, deliciousness of the potato salad they prepared, and positive emotions associated with trying vegetables.
Photographic records of cooked food and leftovers (Evaluation time points: two times in total, upon completion of cooking and after tasting) Content: Qualitative and objective evaluation of the ingenuity of the completed dishes and the amount of leftovers (changes in vegetable intake) through photographs.

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Cooking activities using potato salad (child-led cooking and parent's observation) Under the guidance and assistance of the research staff, subjects will prepare an arranged potato salad. During the cooking process, parents will observe their children, providing encouragement and setting an environment that allows the children to proactively engage in the activities.

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

Age-lower limit

6

years-old

<=

Age-upper limit

12

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Elementary school children (1st to 6th grade, aged 6 to 12 years) and their parents/guardians.
2.Those whose parents/guardians have received sufficient explanation about this study, understood its contents, and provided written informed consent to participate.
3.Those who (the subjects themselves) have understood the study contents and provided assent to participate (depending on their age and level of understanding).
4.Those who are able to visit the designated study site on the day of the study.

Key exclusion criteria

1.Those who have a physician-diagnosed food allergy to the ingredients to be used in this study (e.g., eggs, wheat, soybeans).
2.Those with severe cardiac, endocrine, or psychiatric disorders, etc.
3.Those who regularly take medications that may affect hormone secretion.
4.Pregnant or breastfeeding parents (Due to altered hormone secretion dynamics, they will be excluded from the primary outcome [saliva collection] and participate only in the secondary outcomes [questionnaires]. Note: Their corresponding children will undergo all measurements as usual).
5.Others deemed inappropriate as study subjects by the principal investigator.

Target sample size

96

Name of lead principal investigator

1st name	ryosuke
Middle name
Last name	matsuoka

Organization

Kewpie corporation

Division name

Research and Development Division

Zip code

1820002

Address

2-5-7 Sengawacho, Chofu, Tokyo

TEL

0353847759

Email

ryosuke_matsuoka@kewpie.co.jp

Name of contact person

1st name	yui / wei
Middle name
Last name	ou / wang

Organization

Kewpie Corporataion

Division name

Research and Development Division

Zip code

1820002

Address

2-5-7 Sengawacho, Chofu, Tokyo

TEL

0353847759

Homepage URL

Email

yui_ou@kewpie.co.jp

Institute

Kewpie Corporation

Institute

Department

Personal name

Organization

Kewpie corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shiba Palace Clinic Institutional Review Board

Address

6F Daiwa A Hamamatsucho Bldg., 1-9-10 Hamamatsucho, Minato-ku, Tokyo

Tel

0354081599

Email

jimukyoku@mail.souken-r.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

07

Month

08

Day

Date of IRB

2026

Year

07

Month

09

Day

Anticipated trial start date

2026

Year

07

Month

09

Day

Last follow-up date

2026

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

23

Day

Last modified on

2026

Year

07

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071315