None listed
Conditions
Interventions
Oral intake of the test product (single ingestion: 2 capsules).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 20-59 years. 2) Individuals who are healthy and have no chronic physical disease including skin disease. 3) Individuals whose written informed consent has been obtained. 4) Individuals who can come to the designated venue for this study and be inspected. 5) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals with serious anemia. 6) Individuals who used a drug to treat a disease in the past 1 month. 7) Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2. 8) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9) Individuals who have and had a habit in the past 1 month to ingest food with functional claims, health foods, or supplements. 10) Individuals who experienced unpleasant feeling during blood drawing. 11) Individuals with drug and food allergies. 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13) Individuals who are or are possibly pregnant, or are lactating. 14) Individuals who participated in other clinical studies in the past 1 month. 15) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood kinetics (Blood hesperetin concentration, AUC(0-7h),iAUC(0-7h), Cmax, Tmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Blood kinetics (AUC(0-inf),T1/2,MRT,Kel) *Safety [1] Doctor's questions. [2] Adverse events *Other indexes [1] Baseline characteristics [2] height measurement [3] Blood pressure, pulsation. [4] Weight, body fat percentage, BMI [5] Infectious disease-related tests | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed