Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060842) titled 'Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness' on March 6.

Study Type: Interventional

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

Primary Sponsor: Institute - Meiji Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the effect of a single intake of the test food on daytime sleepiness in comparison with the control food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Single intake of the test food on the day of the study Interventions/Control_2 - Single intake of the placebo food on the day of the study

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - 1. Adult male full-time employees of the Research Headquarters whose workplace is the Meiji Innovation Center at the time of obtaining consent. 2. Subjects who have received sufficient explanation about the purpose and content of this study, possess the capacity to consent, and have voluntarily agreed to participate after fully understanding the information provided. Key exclusion criteria - 1. Subjects currently receiving treatment (including medication) for any disease. 2. Subjects with a Body Mass Index (BMI) greater than 25. 3. Subjects whose usual sleep duration, calculated from self reported bedtime and wake up time, is less than 6 hours. 4. Subjects with suspected sleep disorders. 5. Subjects unable to comply with study procedures. 6. Subjects engaged in shift work, night work, or whose primary occupation involves physical labor. 7. Subjects who consume excessive amounts of alcohol (defined as consuming more than 1 go of sake [equivalent to one 500 mL bottle of beer, one double shot of whiskey, or 0.6 go of shochu] three or more times per week). 8. Subjects who smoke. 9. Subjects with known food allergies. 10. Subjects with lactose intolerance. 11. Subjects who self identify as caffeine dependent. 12. Subjects currently participating in or planning to participate in another clinical trial at the start of this study. 13. Subjects deemed inappropriate for participation by the principal investigator. Target Size - 12

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 07 Month 16 Day Date of IRB - 2025 Year 07 Month 17 Day Anticipated trial start date - 2025 Year 08 Month 19 Day Last follow-up date - 2025 Year 11 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066977

Disclaimer: Curated by HT Syndication.