The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial
- Conditions
- Healthy subjects with normal level or slightly higher than normal level of fasting serum triglyceride
- Registration Number
- JPRN-UMIN000050594
- Lead Sponsor
- Medical Corporation Shoureikan Shin-Sapporo Seiryou Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Subjects with history of hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious illness. (2) Subjects with a surgical history of digestive system (except appendicectomy). (3) Subjects with chronic diseases under treatment. (4) Subjects with food allergies to the food ingredients used in the study. (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 high-fat foods to show gastrointestinal symptoms. (7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) or excessive smokers (smoke more than 20 cigarettes per day). (8) Subjects who always take drugs or supplements which claim the effects such as 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 have a habit of skipping meals. (13) Subjects who work from 22:00 to 6:00 (shift workers, late night workers, etc., including part-time workers) (14) Subjects who due to religious or other reasons need to avoid consuming foods whose origin is not clearly indicated. (15) Subjects judged as unsuitable for this study by the investigator with other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method