Clinical Trial to Evaluate the Efficacy of Black Garlic in Reducing Cardiovascular Risk in Subjects With Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Impact on blood pressure
研究概览
简要总结
A controlled clinical intervention study is proposed to determine the effect of black garlic consumption on biomarkers of cardiovascular function and associated pathologies in a healthy population at risk for cardiovascular disease. Black garlic is the result of a fermentation process of common white garlic in which the temperature and humidity are kept constant over a long period of time. Black garlic is particularly rich in phenolic compounds such as S-allylcysteine or S-allyl-mercaptocysteine, with antioxidant action. It also provides vitamin C and other valuable antioxidant substances such as flavonoids.
详细描述
A parallel, controlled clinical trial will be performed to assess the effect of garlic on mild hypercholesterolemia.
The study will conducted in two groups of volunteer: healthy and at cardiovascular risk (hypercholesterolemic subjects), consuming black garlic, with each individual acting as its own control. The study will have a total duration of 18 weeks, divided in two stages:
- Stage 1: basal or washout stage of 2 weeks, in which volunteer follow their usual diet with restrictions
- Stage 2: intervention stage of 16 weeks, in which volunteer consume black garlic Sixty healthy volunteers (men and women) between 40-65 years old and BMI between 24.9-29.9 kg/m2 will be recruited. From the total of volunteer, 30 will correspond to the Healthy Group, which should have total blood cholesterol levels less than 200 mg/dL and LDL-cholesterol less than 135 mg/dL.
The other 30 volunteers correspond to the Cardiovascular Risk Group, which should have total cholesterol levels between 200-300 mg/dL and LDL-cholesterol levels between 135-175 mg/dL.
Other inclusion criteria established for all volunteers are: no acute or chronic pathology, (except hypercholesterolemia for the risk group), no taking drugs, hormones or dietary supplements, no smoking, no pregnancy, no vegetarianism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Group:
- •Total blood cholesterol levels of less than 200 mg/dL
- •LDL-cholesterol levels of less than 135 mg/dL
- •Not suffer from any other pathology.
- •No drugs, hormones or dietary supplements, no smoking, no pregnancy, no vegetarianism, etc.
- •Cardiovascular Risk Group:
- •Total cholesterol levels between 200-300 mg/dL
- •LDL-cholesterol levels between 135-175 mg/dL.
- •No acute or chronic pathology, except hypercholesterolemia
- •No drugs, hormones or dietary supplements, no smoking, no pregnancy, no vegetarianism, etc.).
排除标准
- •Failure to meet any of the inclusion criteria
结局指标
主要结局
Impact on blood pressure
时间窗: changes observed from baseline at day 0 compared to 12 weeks.
Blood pressure (diastolic, systolic)
Impact on lipid profile
时间窗: changes observed from baseline at day 0 compared to 12 weeks.
Plasma levels of total cholesterol, HDL, LDL, VLDL (very low-density lipoprotein), triglycerides, apolipoproteins A1 and B.
次要结局
- Impact on blood cells (Hematology)(changes observed from baseline at day 0 compared to 12 weeks.)
- evaluation of liver function to determine product safety(changes observed from baseline at day 0 compared to 12 weeks.)
- Impact on endothelial function(changes observed from baseline at day 0 compared to 12 weeks.)
- Changes in cytokine levels(changes observed from baseline at day 0 compared to 12 weeks.)
- Changes in chemokine MCP-1 (monocyte chemotactic protein)(changes observed from baseline at day 0 compared to 12 weeks.)
- Changes in C reactive protein(changes observed from baseline at day 0 compared to 12 weeks.)
- Impact on glucose levels(changes observed from baseline at day 0 compared to 12 weeks.)
- Impact on glycosylated hemoglobin (HbA1c)(changes observed from baseline at day 0 compared to 12 weeks.)
- Impact in hormones related to metabolism(changes observed from baseline at day 0 compared to 12 weeks.)
研究者
Maria Pilar Zafrilla Rentero
Vicedean of Pharmacy Degree
Catholic University of Murcia