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To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pressed candy | Placebo Comparator |
| |
| CHOLESWISE pressed candy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo pressed candy | Dietary Supplement | consume 2 tablets per day for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure) | Blood pressure will be measured at the beginning, 4-week, and 8-week time points. | Days 1, 28, and 56 |
| Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C) | Blood lipid will be measured at the beginning, 4-week, and 8-week time points. | Days 1, 28, and 56 |
| Change from baseline in blood coagulation factor (factor VII, fibrinogen) | Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points. | Days 1, 28, and 56 |
| Change from baseline in arteriosclerosis | Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points. | Days 1 and 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood glucose | Blood glucose will be measured at the beginning, 4-week, and 8-week time points. | Days 1, 28, and 56 |
| Change from baseline in blood hs-CRP | Blood hs-CRP will be measured at the beginning 8-week time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Fengxian District Central Hospital | Shanghai | 201499 | China |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| CHOLESWISE pressed candy |
| Dietary Supplement |
consume 2 tablets per day for 8 weeks |
|
|
| Days 1 and 56 |