Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059833) titled 'Examination of the effects of test food intake on objective and subjective flow states' on Nov. 20.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Pharma Foods International Co., Ltd.

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

Objective: Narrative objectives1 - The purpose of this study is to examine the effects of a single dose of test food on objective and subjective flow states and game performance during game play in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A single administration of the test food is performed. After a washout period, a single administration of placebo is performed. Interventions/Control_2 - A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - a. healthy men and woman aged 18 years or older at the time of consent. b. people who regularly play games. c. people who have received a full explanation of the purpose and content of the study, are competent to consent, fully understand the content, and voluntarily volunteer to participate in the study and provide written consent. Key exclusion criteria - a. taking medication or under medical treatment b. under exercise therapy or dietetic therapy c. allergic to test food d. current dependence or history of either medicine or alcohol dependence syndrome e. current or prior diagnosis of mental illness (depression) or sleep disturbance f. on a night-shift or shift worker g. extremely irregular lifestyle h. unbalanced diet i. current or past history of serious illnesses such as diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal gland disease, or other metabolic disorders. j. excessive amounts of energy drinks. k. participation in other clinical studies within the past 3 months from the day of consent or planning to participate in other clinical studies during the current study. l. pregnant, lactating, or intending to become pregnant during the study period m. deemed unsuitable as subjects based on EEG measurements during SCR. n. considered as an inappropriate candidate by the doctor in charge. Target Size - 11

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 13 Day Date of IRB - 2025 Year 11 Month 14 Day Anticipated trial start date - 2025 Year 11 Month 20 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068425

Disclaimer: Curated by HT Syndication.