Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060433) titled 'Trial on the Effects of Food Ingredient Intake on Postprandial Drowsiness(SIC-2026-01-BLG)' on Jan. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Suntory Global Innovation Center Ltd.

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

Objective: Narrative objectives1 - To evaluate the effects of food ingredients intake on postprandial drowsiness Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - After consuming the test food once, a washout period will follow, and the control food will be consumed once. After a washout period, repeat the same intake method. Interventions/Control_2 - After consuming the control food once, a washout period will follow, and the test food will be consumed once. After a washout period, repeat the same intake method.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy males and females in the age between 20 and 64 years (2) Subjects who can come to the designated examination facility on the scheduled visit date (3) Subjects who can submit the written informed consent form Key exclusion criteria - (1) Subjects who regularly consume pharmaceuticals or quasi-drugs that may affect the efficacy evaluation of the test food (2) Subjects who continuously consume food for specified health use, functional foods, or health foods that may affect the efficacy evaluation of the test food (3) Subjects whose lifestyle is scheduled to change drastically before or after the start of the study (including business trip, travel, etc. that will significantly change the rhythm of their daily life) (4) Subjects who are currently participating in other studies, who have participated in other studies within 4 weeks after their completion, or who are planning to participate in other studies during the study period (5) Other subjects who are judged by the investigator as unsuitable for the study Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 21 Day Date of IRB - 2026 Year 01 Month 21 Day Anticipated trial start date - 2026 Year 01 Month 22 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069137

Disclaimer: Curated by HT Syndication.