A Study on the Effect of Food Containing Plant Extract on LDL-cholesterol Levels -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000032136
- 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
- 100
Not provided
(1) Subjects who habitually use medications. (2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, and so on during test periods. (3) Subjects who can't stop drinking from 2 days before each measurement. (4) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (5) Subjects who have declared allergic reaction to ingredients of test foods. (6) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (7) Subjects who are shiftworker and/or midnight-shift worker. (8) Subjects who have been diagnosed as familial hyperlipidemia. (9) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating. (10) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (11) 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 DL-cholesterol
- Secondary Outcome Measures
Name Time Method