The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
研究概览
简要总结
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
详细描述
This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
时间窗: 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 pressure (systolic blood pressure, diastolic blood pressure)
时间窗: Days 1, 28, and 56
Blood pressure will be measured at the beginning, 4-week, and 8-week time points.
Change from baseline in arteriosclerosis
时间窗: Days 1 and 56
Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.
Change from baseline in blood coagulation factor (factor VII, fibrinogen)
时间窗: Days 1, 28, and 56
Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.
次要结局
- Change from baseline in blood hs-CRP(Days 1 and 56)
- Change from baseline in blood glucose(Days 1, 28, and 56)