Clinical Trial: Study on blood concentration levels of the test food during continuous intake (Japan)

Tokyo, March 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060838) titled 'Study on blood concentration levels of the test food during continuous intake' on March 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - KANEKA CORPORATION

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the Bio-availability of four different test foods upon consecutive consumption in humans Basic objectives2 - Bio-availability

Intervention: Interventions/Control_1 - Ingestion of test food A for 4 consecutive weeks Interventions/Control_2 - Ingestion of test food B for 4 consecutive weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - 1) Healthy males aged of 20-44 years 2) Subjects whose BMI18.5 kg/m2 <= and <25.0 kg/m2 3) Subjects who eat three meals a day(Subjects who are able to eat three meals a day during the intake period) 4) Subjects who can visit the clinic on the scheduled visit date 5) Subjects who agreed in writing with sufficient understanding of the purpose and contents of this study Key exclusion criteria - 1) Subjects who have systolic blood pressure <90 mmHg 2) Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks 3) Subjects who participated in other clinical studies in the past 4 weeks or who are scheduled to participate in another study during the study period 4) Subjects who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to the test food e) Subjects with a positive or suspected positive test for infectious diseases 5) Subjects who are under treatment at the time of obtaining consent to participate in the study 6) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection 7) Subjects who have some kind of food allergy 8) Subjects who have experienced sickness due to blood collection 9) Subjects who have difficulty drawing blood from the peripheral vein 10) Heavy drinker (over 40g alcohol/day) 11) Subjects who quit smoking for less than 6 months or smokers 12) Subjects who are shift workers and night workers 13) Subjects who regularly use, or have regularly taken within the past month, oral medications or supplements that may affect this study 14) Subjects judged as unsuitable for this study by the principal investigator Target Size - 64

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 24 Day Date of IRB - 2026 Year 03 Month 03 Day Anticipated trial start date - 2026 Year 03 Month 06 Day Last follow-up date - 2026 Year 05 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069609

Disclaimer: Curated by HT Syndication.