Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059501) titled 'Blood kinetics study of single intake of plant extract' on Oct. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - FANCL Corporation

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

Objective: Narrative objectives1 - To investigate the absorption of active compounds in blood following a single oral administration of a plant extract. Basic objectives2 - Pharmacokinetics

Intervention: Interventions/Control_1 - Single intake of test food

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women aged 20 to 60 years old at the time of obtaining consent 2) BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 3) Subjects who can participate in dietary interventions, intake of the test foods, blood samplings, urine samplings, and maintain rest as scheduled. 4) Subjects with decisional capacity to provide informed consent Key exclusion criteria - 1)Subjects with a serious medical history, or with a history of disorders of the digestive system, circulatory system (e.g., heart failure), endocrine system, etc. 2)Subjects who have a history of gastrointestinal resection surgery, excluding appendectomy. 3)Subjects who have a disease that affects gastric excretion and digestion/absorption, or who regularly experience symptoms of indigestion, constipation, diarrhea, etc. 4) Subjects with abnormalities in renal function, liver function, blood pressure, glucose and lipid metabolism 5)Subjects who are currently taking medication or being treated by a physician. 6)Subjects who must be scheduled to receive medical treatment or medication during the study period. 7)Subjects who plan to consume health foods or supplements other than the food under study after consent. 8)Subjects who are unable to consume the test food due to preference or allergy. Subjects who may have allergies related to the test food. 9)Heavy drinkers of alcohol and smokers. 10)Subjects who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks. 11)Subjects who currently or will be participating in another clinical research study during the study period. 12)Subjects who have irregular sleep or eating habits due to night work or insomnia. 13)Subjects who are engaged in strenuous physical activity. 14)Subjects judged as unsuitable for the study by the responsible doctor for other reasons. Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 03 Day Date of IRB - 2025 Year 10 Month 10 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2025 Year 11 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068049

Disclaimer: Curated by HT Syndication.