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To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | consume 1 sachet per day for 2 months |
|
| Buckwheat husk extract | Experimental | consume 1 sachet per day for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | consume 1 sachet per day for 2 months |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Body Mass Index (BMI) | Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points. P.S. weight in kilograms, height in meters | Days 1, 28, and 56 |
| Change from baseline in waist-hip ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shyr-Chyr Chen | Contact | (02) 23123456 | scchen@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Mao-Hsin Lin, Doctor | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 114 | Taiwan |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Buckwheat husk extract |
| Dietary Supplement |
consume 1 sachet per day for 2 months |
|
Waist-hip ratio 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 cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide) | Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points. | Days 1, 28, and 56 |