A Study on the Effect of Food Containing Polydextrose on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
- o (Subjects with high fasting serum triglyceride)
- Registration Number
- JPRN-UMIN000014538
- 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 medication affecting lipid metabolism. (2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting lipid metabolism. (3)Subjects who can't stop drinking for 2 days before the screening checkup or each measurement. (4)Subjects who have declared allergic reaction to ingredients contained in high-fat diets. (5)Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (6)Subjects who have a chronic disease and use medicines continuously. (7)Subjects who have a history of digestive disease affecting digestion and absorption. (8)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator. (9)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. (10)Subjects who are diagnosed as familial hyperlipidemia. (11)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (12)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (13)Subjects who are planning to participate in other clinical studies. (14)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (15)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postprandial Serum Triglyceride
- Secondary Outcome Measures
Name Time Method