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

Tokyo, Sept. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062876) titled 'Effects of food consumption on emotions and engagement in creative tasks among elementary school children: a randomized crossover trial' on Sept. 11.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Macromill Carenet, Inc.

Condition: Condition - Healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 10 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 Size - 44

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071969

Disclaimer: Curated by HT Syndication.