Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060674) titled 'Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2)' on Feb. 14.

Study Type: Interventional

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

Primary Sponsor: Institute - EP Mediate Co., Ltd.

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

Objective: Narrative objectives1 - This study compares fatigue, drowsiness, and core body temperature following a single intake of test food as a placebo control. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of test food C (single serving) - washout period - (single serving)- placebo D (single serving) Interventions/Control_2 - Intake of placebo D (single serving) - washout period - test food C (single serving)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy males and females from 20 to 70 years of age. (2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study. Key exclusion criteria - (1) Subjects who regularly consume foods containing test food ingredients. (2) Subjects who are currently consuming health foods such as foods for health uses or foods with functional claims and cannot discontinue them during participation in this trial. (3) Subjects who may be at risk of developing allergies in relation to the research. (4) Subjects with a history of treatment for malignant tumors, heart failure, or myocardial infarction. (5) Individuals undergoing treatment for chronic diseases or with a medical history. Arrhythmia, liver dysfunction, kidney dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases. (6) Subjects who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment. (7) Subjects with pacemakers or other implantable medical devices. (8) Subjects unable to attach devices for core body temperature measurement (chest) and peripheral temperature measurement (back of the hand), and perform tests according to procedure.hand). (9) Subjects Subjects who are judged to be unsuitable for participation in the study based on their responses to the or pre-intak.. (10) Subjects who work in shifts, night shifts, or have irregular daily schedules. (11) Subjects who participated in other clinical studies during the one-month period prior to study enrollment (pre-screening). (12) Subjects who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study period. (13) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey. (14) Subjects who are judged as unsuitable for the study by the investigator for other reason Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 29 Day Date of IRB - 2026 Year 01 Month 29 Day Anticipated trial start date - 2026 Year 02 Month 14 Day Last follow-up date - 2026 Year 06 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069397

Disclaimer: Curated by HT Syndication.