The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

Study Overview
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Brief Summary
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To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

Detailed Description
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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.

Official Title
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The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Buckwheat husk extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg. Those who are not pregnant and are willing to cooperate with contraception during the trial period. No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history). Exclusion Criteria: Pregnant women. People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history). No person has undergone major surgery.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>consume 1 sachet per day for 2 months | Dietary Supplement: Placebo<br>* consume 1 sachet per day for 2 months<br>|
| Experimental: Buckwheat husk extract<br>consume 1 sachet per day for 2 months | Dietary Supplement: Buckwheat husk extract<br>* consume 1 sachet per day for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |