Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062257) titled 'Bioequivalence Study of Beverages Containing Green Tea Catechin Extracts: A Randomized, Single-Blind, Crossover Trial' on July 21.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Central Research Institute, ITO EN, Ltd.

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

Objective: Narrative objectives1 - To evaluate the absorption and metabolism of catechins. Basic objectives2 - Pharmacokinetics

Intervention: Interventions/Control_1 - Single Administration of Catechin-Containing Beverage A Interventions/Control_2 - Single Administration of Catechin-Containing Beverage B

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - ealthy male and female employees of the R&D Division, SCM Division, or Manufacturing Division of ITO EN, Ltd., aged 18 years or older and younger than 60 years at the time of providing written informed consent. Key exclusion criteria - a. Individuals receiving pharmacological treatment for any disease. b. Individuals with severe anemia. c. Individuals with known or suspected allergies to the test beverage or any foods consumed during the study period. d. Individuals with a current or past history of gastrointestinal disease, cardiovascular disease, nephritis, hepatitis, pancreatitis, or other clinically significant diseases, or those with severe psychiatric disorders. e. Individuals who are likely to experience changes in their lifestyle during the study period (e.g., night-shift work or extended travel). f. Current smokers. g. Individuals who routinely consume Foods for Specified Health Uses (FOSHU) or Foods with Function Claims (FFC). h. Individuals who regularly use medications (including herbal medicines) or dietary supplements. i. Individuals who are pregnant, breastfeeding, or intending to become pregnant during the study period. j. Individuals considered unsuitable for participation in the study by the principal investigator. Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 30 Day Date of IRB - 2026 Year 04 Month 13 Day Anticipated trial start date - 2026 Year 07 Month 15 Day Last follow-up date - 2026 Year 07 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071237

Disclaimer: Curated by HT Syndication.