Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055696) titled 'Study on the psychological effects of the test beverage' on Oct. 2.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - HUMA R&D CORP

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

Objective: Narrative objectives1 - To study the psychological effects on ingesting the test beverage on Japanese males and females aged 20 to 35. Basic objectives2 - Safety,Efficacy

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

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1.Japanese males and females who are between 20 and 35 years of age at the time of written informed consent. 2.Subject with BMI <25.0kg/m2. 3.Non-smokers. (no smoking in the last year) 4.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.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin (chest), etc.) 7.Heavy drinker. 8.Subject who has difficulty quitting drinking from the day before the test date. 9.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. 10.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. 11.Subject who has moved residences, changed jobs, separated from close relatives, or had equivalent events within the last 3 months and thus are likely to be under a great deal of stress, or who may have such an event during the study period. 12.Subject who exercises violently on a daily basis. 13.Subject who is aware of frequent urination 14.Subject with severe PMS (premenstrual syndrome) symptoms. 15.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period. Target Size - 63

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 09 Month 06 Day Date of IRB - 2024 Year 09 Month 13 Day Anticipated trial start date - 2024 Year 10 Month 03 Day Last follow-up date - 2024 Year 11 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063540

Disclaimer: Curated by HT Syndication.