Healthy subjects with normal to slightly higher fasting serum triglyceride levels
Conditions
Interventions
single ingestion of the placebo food - washout period (6 days and more) - single ingestion of the test food
single ingestion of the test food - washout period (6 days and more) - single ingestion of t
Sponsors
Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females between the ages of 20 and 64 years old at the time of obtaining consent to participate in the study. 2. Healthy subjects with normal to slightly higher fasting serum triglyceride levels at pre-screening, and whose time courses of serum TG after loading dietary food resemble each other at 1st and 2nd screening. 3. Subjects available at every designated visit. 4. Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. 2. Subjects with a surgical history of digestive system (except appendicectom). 3. Subjects currently under treatment with chronic diseases. 4. Subjects with food allergies to the food ingredients used in the test. 5. Subjects who are pregnant or intend to become pregnant during the study or are lactating. 6. Subjects who are lactose intolerant or are susceptible to gastrointestinal symptoms of high-fat foods. 7. Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) and excessive smokers (smoke more than 20 cigarettes per day). 8. Subjects who always take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc. 9. Subjects who participate in other clinical trial. 10. Subjects who may feel unwell or deteriorate due to repeated blood collection. 11. Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study. 12. Subjects who do not take breakfast. 13. Subjects who work from 22:00 to 6:00 (shift worker, night- shift worker, etc.) 14. Subject who cannot consume foods whose origin is not clearly indicated due to religious or other reasons. 15. Subjects judged as unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the area under the curve of postprandial serum triglyceride level when placebo and test food are consumed | — |
Secondary
| Measure | Time frame |
|---|---|
| The comparison of the area under the curve and the level at each measuring point of Remnant-like particles-cholesterol and chylomicron-TG when placebo and test food are consumed. The comparison of the level at each measuring point of postprandial serum triglyceride when placebo and test food are consumed. | — |
Countries
Japan
Contacts
Public ContactIsao Takehara
Clinical Support Corporation Limited Food Service Division
Outcome results
None listed