The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health
Study Details
Study Description
Brief Summary
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo pressed candy
|
Dietary Supplement: Placebo pressed candy
consume 2 tablets per day for 8 weeks
|
| Experimental: CHOLESWISE pressed candy
|
Dietary Supplement: CHOLESWISE pressed candy
consume 2 tablets per day for 8 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure) [Days 1, 28, and 56]
Blood pressure will be measured at the beginning, 4-week, and 8-week time points.
- Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C) [Days 1, 28, and 56]
Blood lipid will be measured at the beginning, 4-week, and 8-week time points.
- Change from baseline in blood coagulation factor (factor VII, fibrinogen) [Days 1, 28, and 56]
Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.
- Change from baseline in arteriosclerosis [Days 1 and 56]
Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.
Secondary Outcome Measures
- Change from baseline in blood glucose [Days 1, 28, and 56]
Blood glucose will be measured at the beginning, 4-week, and 8-week time points.
- Change from baseline in blood hs-CRP [Days 1 and 56]
Blood hs-CRP will be measured at the beginning 8-week time points.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 30 years old, no gender limit;
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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;
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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;
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People who voluntarily agree and sign an informed consent form.
Exclusion Criteria:
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People with a history of dyspepsia would affect the absorption of the test product;
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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;
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People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders;
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Pregnant or breast-feeding women or women who have a positive result on a pregnancy test;
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Allergic to the components of the test product;
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Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Fengxian District Central Hospital | Shanghai | China | 201499 |
Sponsors and Collaborators
- TCI Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-KY-24-01