A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o(subjects with fasting serum triglyceride levels 30-199 mg/dL)
- Registration Number
- JPRN-UMIN000015999
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1)Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism, and so on (2)Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism, and so on (3)Subjects who contract serious diabetes, kidney disease, liver disease, and/or disease needing immediate treatment, and who are taking relevant medicines (4)Subjects who have a history of digestive disease affecting digestion and absorption, and related surgery (5)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism (6)Subjects who have been diagnosed as familial hyperlipidemia (7)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating (8)Subjects who have donated blood components and/or blood a volume of 200 mL and over within one month prior to the current study (9)Subjects who are planning to participate or already participating in other clinical studies (10)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 Biochemical examination, Hematological examination, urine analysis, vital signs
- Secondary Outcome Measures
Name Time Method