Healthy subjects
Conditions
Interventions
Stage1: Placebo capsule Stage2: Test substance A capsule Stage3: Test substance B capsule Fat Loading Food d: Corn Oil Suspended with 3% Gum Arabic After eating the fat loading food within 3 min
Sponsors
Takasaki University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females aged 20 years or older at the time of informed consent. In principle, those whose fasting blood TG level at the time of screening test is less than 150mg/dL. Those who fully understand the purpose and safety of this research specified in the research cooperation consent form and have obtained consent.
Exclusion criteria
Exclusion criteria: Persons receiving treatment, medication, or lifestyle guidance from a doctor due to dyslipidemia or diabetes. People who regularly use medicines, health foods, or supplements that affect blood lipids. Persons who have some kind of disease and are receiving medication and are deemed unsuitable as subjects by the research doctor. Persons who may have allergic symptoms related to rubber or latex. Persons who may develop allergic symptoms regarding fat-loaded foods (corn oil, etc.). Persons whose HIV antigen/antibody, HBs antigen, HCV antibody, or syphilis test result was positive at the time of screening. Persons with obvious abnormalities found in hematological or biochemical tests. Those who are pregnant, wish to become pregnant during the test, or are breastfeeding. Persons whose TG delta C3h (estimated TGCmax) is less than 30 mg/dL in the screening test. Those who have been diagnosed with bronchial asthma and are receiving treatment, or those who have received treatment in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve (AUC) of the postprandial serum triglyceride. | — |
Secondary
| Measure | Time frame |
|---|---|
| The maximum concentration (Cmax) of the postprandial serum triglyceride. The serum triglyceride level (before, 60, 90, 120, 240 and 360 minutes after the fat food load). | — |
Countries
Japan
Contacts
Public ContactSatsuki Kimura
Takasaki University of Health and Welfare Faculty of Pharmacy
Outcome results
None listed