The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

Study Overview
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Brief Summary
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To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors

Detailed Description
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This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.

Official Title
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The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Placebo pressed candy
* Dietary Supplement: CHOLESWISE pressed candy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 30 years old, no gender limit; Patients with high blood pressure (systolic blood pressure> 120 mmHg or diastolic blood pressure> 80 mmHg) or high blood lipids (TC ≥ 5.18 mmol/L or TG ≥ 1.7 mmol/L), and no medication is used; Fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions; People who voluntarily agree and sign an informed consent form. Exclusion Criteria: People with a history of dyspepsia would affect the absorption of the test product; Any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease; People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders; Pregnant or breast-feeding women or women who have a positive result on a pregnancy test; Allergic to the components of the test product; Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.

Ages Eligible for Study
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Minimum Age: 30 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pressed candy<br> | Dietary Supplement: Placebo pressed candy<br>* consume 2 tablets per day for 8 weeks<br>|
| Experimental: CHOLESWISE pressed candy<br> | Dietary Supplement: CHOLESWISE pressed candy<br>* consume 2 tablets per day for 8 weeks<br>* Other names: Natto combined Phyllanthus emblica pressed candy;|

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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Days 1 and 56 |