Tokyo, Jan. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060377) titled 'Confirmation of the hydration effect of food intake on the body' on Jan. 16.

Study Type: Interventional

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

Primary Sponsor: Institute - Transgenic Inc.

Condition: Condition - Healthy male adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effect of a single intake of test foods on hydration of the body in males aged 20 to 65. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The test food is ingested once. Interventions/Control_2 - The control food is ingested once.

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - (1) Men aged 20 years or older at the time of consent and under 65 years old at the end of the study (2) Subjects who can be admitted to a designated facility on the scheduled date of visit (3) Subjects who can enter data into an electronic diary using a PC, smartphone, etc. (4) Those who have fully understood the purpose and content of this study and have obtained written consent. Key exclusion criteria - 1. Systolic blood pressure less than 90 mmHg. 2. Donated blood components or 200 mL or more whole blood within 4 weeks before study start. 3. Donated 400 mL or more whole blood within 12 weeks before study start. 4. Total blood drawn from the month before study start plus planned study draws exceeds 1200 mL. 5. Participating in other studies within 4 weeks after another study or planning other study participation during this study. 6. Any of the following a. Heart liver gastrointestinal or kidney disease including complications b. History of circulatory disease c. Diabetes d. Allergy to test or prescribed food e. History of serious diseases such as cancer or tuberculosis 7. Undergoing medical treatment at screening SCR. 8. Regular use of drugs or quasi-drugs. 9. Smoking 11 cigarettes per day or more. 10. Average daily alcohol over 60 g or drinking more than 6 days per week. 11. Extremely irregular eating habits. 12. Shift or late-night worker. 13. Severe anemia. 14. History of poor mood or physical condition after blood sampling. 15. Difficulty with peripheral blood collection or major gastrointestinal surgery history such as gastrectomy gastrointestinal suturing or intestinal resection. 16. Deemed unsuitable by principal or sub-investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 18 Day Date of IRB - 2025 Year 12 Month 16 Day Anticipated trial start date - 2026 Year 01 Month 19 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069067

Disclaimer: Curated by HT Syndication.