Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057973) titled 'Detection of early biological responses induced by a food component (preliminary study)' on May 31.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Yakult Honsha Co., Ltd.

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

Objective: Narrative objectives1 - Evaluate the potential of blood testing to detect changes in proteins induced by a food component that activates vagal afferents through stimulation of enteroendocrine cells. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Single intake of the test food -> 2-week washout period -> Single intake of the placebo Interventions/Control_2 - Single intake of the placebo -> 2-week washout period -> Single intake of the test food

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - 1.Healthy males aged 20 to below 60 years at the time of consent acquisition. 2.Office workers 3.Subjects whose average sleep duration is over 6 hours 4.Subjects whose day-to-day variability in bedtime and wake-up time on weekdays is within 2 hours. 5.Subjects who can go to bed before midnight on the day before the test. 6.Subjects who commute by walking or biking (with the duration of approx. 5 to 30 minutes) 7.Subjects who give written informed consent, after receiving a detailed explanation of the study protocol and understanding the provided information. Key exclusion criteria - 1.Subjects with a history or current diagnosis of mental disorders, chronic fatigue syndrome, sleep disorders, brain injury, brain dysfunction, learning disabilities, or dementia. 2.Subjects with a history or current diagnosis of diabetes, liver disease, kidney disease, heart disease, respiratory disease, diseases affecting adrenal cortex hormone secretion, or other metabolic diseases. 3.Subjects who are currently undergoing medication treatment. 4.Subjects who have smoking habits. 5.Subjects who daily take excessive alcohol. 6.Subjects who are unable to refrain from exercise on the test day (excluding physical activity related to commuting) until the end of blood sampling. 7.Subjects whose sleep environment may change significantly due to long-term business trips or travel during the study period. 8.Subjects who have a participation in other clinical trials within the last 4 weeks or are intended to participate. 9.Subjects who have allergies to medications and/or food. 10.Subjects who have been considered ineligible for participation in the trial by the investigators. Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 04 Month 16 Day Date of IRB - 2025 Year 04 Month 16 Day Anticipated trial start date - 2025 Year 05 Month 22 Day Last follow-up date - 2025 Year 07 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066245

Disclaimer: Curated by HT Syndication.