Cardiovascular Diseases
Conditions
Brief summary
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
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.
Interventions
DIETARY_SUPPLEMENTPlacebo pressed candy
consume 2 tablets per day for 8 weeks
DIETARY_SUPPLEMENTCHOLESWISE pressed candy
consume 2 tablets per day for 8 weeks
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed