Tokyo, Dec. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060035) titled 'Effects of Test Food Intake During Mental Work Tasks on Flow -Non-Blinded, Crossover Study-' on Dec. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - APO PLUS STATION CO., LTD.

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A study will be conducted on healthy adult males to clarify the effects of the test food on flow states. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Main Test Phase I (Test Food) => Washout => Main Test Phase II (Control Food) Interventions/Control_2 - Main Test Phase I (Control Food) => Washout => Main Test Phase II (Test Food)

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - 1) Healthy White males aged 18 to 35 years at the time of informed consent 2) Individuals who are able to present health examination results conducted within the past year 3) Individuals without a habit of consuming test foods (3 cups or fewer per week) 4) Individuals who received a thorough explanation of the study's purpose and procedures, and signed the informed consent form prior to the start of the study Key exclusion criteria - 1) Individuals who are currently undergoing treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2) Individuals currently receiving treatment for the following chronic conditions: Arrhythmia, liver dysfunction, kidney dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases 3) Individuals receiving treatment for cardiovascular diseases such as arrhythmia 4) Individuals with severe symptoms of rhinitis 5) Individuals exhibiting symptoms of alcohol dependence or caffeine intoxication 6) Individuals who regularly medications (including herbal medicines), quasi-drugs, or supplements that may affect test parameters 7) Individuals who regularly consume Foods for Specified Health Uses (FOSHU), foods with functional claims, or other foods/beverages with potential functional properties that may affect test parameters 8) Individuals who has a smoking habit 9) Individuals experiencing physiological effects from water or Test food consumption (e.g., diarrhea, gastritis, stomach pain, etc.) 10) Individuals who are unable to understand English 11) Individuals who are unable to perform tests involving computer use following instructions in English 12) Individuals who do not agree to have the examination session recorded 13) Individuals who have participated in another clinical trial within 3 months prior to the date of consent acquisition, or who are scheduled to participate in another trial during the study period 14) Other individuals deemed unsuitable for participation in this trial by the principal investigator Target Size - 26

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 03 Day Date of IRB - 2025 Year 12 Month 03 Day Anticipated trial start date - 2025 Year 12 Month 11 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068637

Disclaimer: Curated by HT Syndication.