A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000032218
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
(1) Subjects who use oral medications affecting lipid metabolism. (2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting lipid metabolism during test periods. (3) Subjects who can't stop drinking from 2 days before each measurement. (4) Subjects who have declared allergic reaction to ingredients contained in test foods or high-fat diets. (5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (6) Subjects who have a chronic disease and use medications continuously. (7) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (8) Subjects who are judged as unsuitable for the current study based on the results of screening tests by the investigator. (9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (10) Subjects who are prone to diarrhea. (11) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (12) Subjects who have been diagnosed as familial hyperlipidemia. (13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (14) Subjects who are planning to participate and/or have participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method