Healthy adults
Conditions
Interventions
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the serum concentration time curve (iAUC) from the pre dose baseline for the active compounds from plant extract. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum serum concentration (Cmax) of the active compounds from plant extract; serum concentration at each blood-sampling time point; time to reach maximum serum concentration (Tmax); and elimination half-life (t1/2) of the active compounds from plant extract. | — |
Countries
Japan
Contacts
Public ContactNaoyuki Abe
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic Clinical Trial Division
Outcome results
None listed