Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057835) titled 'A study to evaluate the effect of the test product on cognitive function' on May 12.

Study Type: Interventional

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

Primary Sponsor: Institute - HUMA R&D CORP

Condition: Condition - Healthy subjects Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The study will be conducted to examine the effects of the components of the test product on cognitive function in Japanese males and females aged 20 to less than 60. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake placebo beverage A on the day Washout Intake test beverage on the day Washout Intake placebo beverage B on the day Interventions/Control_2 - Intake test beverage on the day Washout Intake placebo beverage B on the day Washout Intake placebo beverage A on the day

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Japanese males and females who are aged 20 to less than 60 at the time of written informed consent. 2.Non-smokers. (no smoking in the last year) 3.Subjects who are able to 1 bottle of beer, totaling about 350mL 4.Subjects who hold Driver's License and drive a car regularly 5.Subject who is fully explained the purpose and details of the study, has ability to consent, is volunteering to participate in the study with a full understanding of the explanation, and has consented to participate in the study in writing. Key exclusion criteria - 1.Subject receiving medication or outpatient treatment for a serious disease. 2.Subject receiving exercise or diet therapy under the supervision of a physician. 3.Subject who has currently taking any products (e.g., foods for specified health use, foods with functional claims, dietary supplements or health foods, drugs, quasi-drugs) that can affect the autonomic nervous system, metabolism, or sleep, and are unable to discontinue taking them during the study period. 4.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 5.Subject with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc. 6.Heavy drinker. 7.Subject who has difficulty quitting drinking from the day before the test date. 8.Subject who has extremely irregular eating habits, those who have an extremely irregular rhythm of life, such a those who work in shifts or late at night. 9.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study. 10.Subject who is aware of frequent urination 11.Subject with severe PMS (premenstrual syndrome) symptoms. 12.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period. 13.Subject who has difficulty in evaluating flavors and aromas because of conditions such as allergic rhinitis. 14.Subject who is allergic to medicines or food. 15.Subject with current or former drug or alcohol dependence. Target Size - 45

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 04 Month 04 Day Date of IRB - 2025 Year 04 Month 11 Day Anticipated trial start date - 2025 Year 05 Month 13 Day Last follow-up date - 2025 Year 07 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065926

Disclaimer: Curated by HT Syndication.