Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061697) titled 'Pharmacokinetics study of food compounds' on May 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Suntory Wellness Limited

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

Objective: Narrative objectives1 - To evaluate the pharmacokinetics of food compounds. Basic objectives2 - Pharmacokinetics

Intervention: Interventions/Control_1 - Food 1 intake -> washout period -> Food 2 intake -> washout period -> Food 3 intake Interventions/Control_2 - Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 1 intake

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - (1) Healthy males who are 20 years of age or older at the time of obtaining consent and under 65 years of age at the end of the intake period (2) Individuals who fully understand the purpose and details of this study and provide written informed consent Key exclusion criteria - (1)Individuals who are currently participating in another study as study subjects, who have participated in another study within 4 weeks after its completion. (2)Individuals who fall under any of the following categories: a) Individuals who have diseases of the heart, liver, or kidneys (including when such diseases are complications of other conditions) b) Individuals with a history of cardiovascular disease c) Individuals who have developed diabetes d) Individuals who have allergies to the test food (including load food or controlled diet, etc.) e) Individuals with a history of serious diseases such as cancer or tuberculosis. (3)Individuals who are receiving any kind of medical treatment at the time of obtaining consent. (4)Individuals with reduced renal function. (5)Individuals with a history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection. (6)Individuals who regularly consume Foods for Specified Health Uses (FOSHU), health food products, or other products that may affect the study results. (7)Individuals who the principal investigator determines to have difficulty swallowing capsules. (8)Individuals whose screening test results for syphilis, HBs antigen, HCV antibody, or HIV antigen/antibody are not negative. (9)Individuals who are judged by the principal investigator or sub-investigator to be unsuitable as study subjects Target Size - 24

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 11 Day Date of IRB - 2026 Year 05 Month 11 Day Anticipated trial start date - 2026 Year 05 Month 18 Day Last follow-up date - 2026 Year 07 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070598

Disclaimer: Curated by HT Syndication.