A clinical study for evaluating of the suppressive effect of a supplement containing complex ingredients on the elevation of serum triglyceride.
- Conditions
- Healthy subjects with normal to slightly higher fasting serum triglyceride levels
- Registration Number
- JPRN-UMIN000045632
- Lead Sponsor
- Medical Corporation Shoureikan Sinsapporo seiryou Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The comparison of the area under the curve of postprandial serum triglyceride level when placebo and test food are consumed
- Secondary Outcome Measures
Name Time Method 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.