UMIN-ICDS Clinical Trial

Public title

Effects of food consumption on emotions and engagement in creative tasks among elementary school children: a randomized crossover trial

Acronym

Effects of food consumption on emotions and engagement in creative tasks among elementary school children: a randomized crossover trial

Scientific Title

Effects of food consumption on emotions and engagement in creative tasks among elementary school children: a randomized crossover trial

Scientific Title:Acronym

Effects of food consumption on emotions and engagement in creative tasks among elementary school children: a randomized crossover trial

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore, in a single-center, within-subject, randomized crossover trial in healthy 5th- and 6th-grade elementary school children, the differences observed between a condition in which food and water are consumed (food condition) and a condition in which only water is consumed (control condition) with respect to (1) emotional states, (2) the process of engaging in creative tasks, and (3) creative output, and to explore the association between changes in emotional states and (2) and (3). This study is not intended to verify the action of specific components of test food, nor effects specific to test food in comparison with other foods.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Between-condition difference in indicators of performance on the creative tasks, covering both the process of engaging in the tasks and the resulting output. The indicators are derived from drawing logs, completed images and audio recordings obtained during the tasks on each visit day (momentum, sustained elaboration, originality, variety, elaboration). No single indicator is treated as the primary evaluation; they are assessed together. All indicators are operationally defined for this study.

Key secondary outcomes

Between-condition differences in the following, assessed as secondary outcomes: (1) indicators of emotional states, namely subjective ratings on a 7-point face scale before and after intake and indicators derived from facial video including during task performance; (2) supplementary indicators of creative output, namely structure and completeness in the story creation task and productivity in the figure completion task. All are measured on each visit day.

Study type

Interventional

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

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

[Allocation type X-A] On Day 1 (Saturday), the control condition (water only) with task set A; on Day 2 (the following Sunday), the food condition (test food, approximately 8 g in total, plus water) with task set B. Intake occurs once on each visit day. In both conditions a cup of water is provided and one sip is taken at the time of intake; in the food condition test food is fully consumed. Intake of test food, cacao products and caffeine is restricted from the day before each visit.

Interventions/Control_2

[Allocation type X-B] On Day 1 (Saturday), the control condition (water only) with task set B; on Day 2 (the following Sunday), the food condition (test food, approximately 8 g in total, plus water) with task set A. Intake occurs once on each visit day. In both conditions a cup of water is provided and one sip is taken at the time of intake; in the food condition test food is fully consumed. Intake of test food, cacao products and caffeine is restricted from the day before each visit.

Interventions/Control_3

[Allocation type Y-A] On Day 1 (Saturday), the food condition (test food, approximately 8 g in total, plus water) with task set A; on Day 2 (the following Sunday), the control condition (water only) with task set B. Intake occurs once on each visit day. In both conditions a cup of water is provided and one sip is taken at the time of intake; in the food condition test food is fully consumed. Intake of test food, cacao products and caffeine is restricted from the day before each visit.

Interventions/Control_4

[Allocation type Y-B] On Day 1 (Saturday), the food condition (test food, approximately 8 g in total, plus water) with task set B; on Day 2 (the following Sunday), the control condition (water only) with task set A. Intake occurs once on each visit day. In both conditions a cup of water is provided and one sip is taken at the time of intake; in the food condition test food is fully consumed. Intake of test food, cacao products and caffeine is restricted from the day before each visit.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

12

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Children in 5th or 6th grade of elementary school at the time of obtaining assent
2. Consent obtained from a parent or legal guardian by electronic means
3. Child's agreement (assent) to participate after receiving an explanation of the study's purpose and procedures
4. Ability to understand task instructions in Japanese
5. Ability to follow instructions and engage in the tasks (story creation and drawing tasks)
6. Agreement to participate without a mask (ensuring the full face is visible) to allow recording of facial expressions, posture, and audio using multiple cameras and microphones at the test venue
7. No dislike of chocolate (milk chocolate)
8. No extreme dislike of drawing
9. Anticipated capability to complete the story creation task
10. Ability to attend the pre-test online interview, complete preliminary tasks (figure drawing and story creation tasks), and submit them by the designated method and deadline
11. Agreement to comply with study rules (e.g., restriction of test food, cacao products, and caffeine starting the day before the test; dietary restrictions on the test day; refraining from parental verbal guidance or advice during tasks)

Key exclusion criteria

-Presence of major trauma, inflammation, swelling, or skin diseases on the face
-Difficulty or restricted movement of facial muscles when making facial expressions (e.g., smiling) due to underlying medical conditions
-Known allergy to chocolate, cacao products, or ingredients contained in the test foods (including milk components and soy), allergens processed in shared facilities (egg and wheat), or a history of other severe allergies
-Individuals currently under dietary restrictions
-Inability to participate safely on the test day due to fever, poor health, or bad physical condition
-Individuals deemed unsuitable for participation by the responsible physician or the principal investigator for any reason

Target sample size

44

Name of lead principal investigator

1st name	Soma
Middle name
Last name	Ode

Organization

Macromill Carenet, Inc.

Division name

Clinical Research Solution Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-7108

Email

umin_info@macromillcarenet.jp

Name of contact person

1st name	Natsu
Middle name
Last name	Ikeyama

Organization

Macromill Carenet, Inc.

Division name

Clinical Research Solution Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-7108

Homepage URL

Email

umin_info@macromillcarenet.jp

Institute

Macromill Carenet, Inc.

Institute

Department

Personal name

Organization

LOTTE CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Oruche Human Informatics Research Institute, Inc.

Name of secondary funder(s)

Organization

Ethics Review Committee of Oruche Human Informatics Research Institute, Inc.

Address

#301 Life Shin-Zushi Bldg., 5-6-19 Zushi, Zushi City, Kanagawa 249-0006, Japan

Tel

050-5477-3358

Email

050-5477-3358

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

09

Month

11

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

Preinitiation

Date of protocol fixation

2026

Year

09

Month

09

Day

Date of IRB

2026

Year

09

Month

09

Day

Anticipated trial start date

2026

Year

09

Month

11

Day

Last follow-up date

2026

Year

11

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

10

Day

Last modified on

2026

Year

09

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071969