Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Glucose level
研究概览
简要总结
The aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other active ingredients in on the levels of selected markers associated with cardiovascular diseases in people with a predisposition to the development of these diseases.
详细描述
Randomized, double-blind, parallel study conducted under medical supervision on a group of 40 patients with known hypertension and/or hypercholesterolemia. Patients receive one of the investigational products or placebo for 6 weeks. Before and after the study, the following parameters are analyzed: extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B), levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), uric acid). Effects on blood pressure and anthropometric parameters are also being evaluated.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men, 18-55 years old
- •Patients with known: hypertension or hypercholesterolemia,
- •Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment
- •Signed informed consent
排除标准
- •Intake of supplements containing plant extracts, polyphenols or anthocyanins,
- •Intake of supplements with antioxidant properties,
- •Participation in another clinical trial,
- •Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
- •Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant,
- •Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease.
- •Patients with signs of inflammation such as increased body temperature, redness, swelling, pain.
- •Patients who have not given written consent to participate in the study.
结局指标
主要结局
Glucose level
时间窗: baseline, 6 weeks
Comparison of glucose level
Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)
时间窗: baseline, 6 weeks
Comparison of lipid panel markers
Systolic, diatolic blood pressure
时间窗: baseline, 6 weeks
Comparison of blood pressure
次要结局
- Homocysteine level(baseline, 6 weeks)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST)(baseline, 6 weeks)
- Insulin level(baseline, 6 weeks)