A clinical study to evaluate LDL cholesterol lowering effect by continuous intake of food containing plant extracts.(SME-2021-05-FOSHUS)
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000046151
- Lead Sponsor
- SUNTORY BEVARAGE & FOOD LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 182
Not provided
(1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion. (2) Women who are/might be pregnant or lactating during the study. (3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake. (4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake. (5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake. (6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (8) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (9) Those who meet any of the following: (a) suffering from heart, liver, or kidney disease (including complications of other diseases) (b) having a history of cardiovascular disease (c) diabetes (d) allergic to test food (10) Those who are receiving any treatment at the time of screening. (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods. (12) Those who smoke an average of 21 or more cigarettes in a day. (13) Those who drink an average of more than 60 g of pure alcohol in a day. (14) Those who have an extremely irregular eating habit. (15) Shift workers or late-night workers. (16) Others who are judged inappropriate for participant by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL cholesterol
- Secondary Outcome Measures
Name Time Method total cholesterol, non-HDL cholesterol, non-HDL cholesterol, triglyceride