Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- LDL
研究概览
简要总结
To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.
详细描述
It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.
64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group.
For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.
Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured.
Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study.
The "pot number" is the same as the "participant number".
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL-cholesterol levels between 100 and 190 mg/dL.
- •Freely agree to participate in the study and sign the informed consent document.
排除标准
- •Be pregnant.
- •Have planned to change lifestyle and / or dietary habits.
- •Having diabetes.
- •Having a cerebrovascular disease.
- •Having a serious illness.
- •Taking products or drugs to control cholesterol levels or with antioxidant activity.
结局指标
主要结局
LDL
时间窗: 8 weeks.
Serum LDL cholesterol
次要结局
- IL1 beta in plasma(8 weeks)
- IL 6(8 weeks)
- Cholesterol(8 weeks)
- Blood pressure(8 weeks)
- Abdominal perimeter(8 weeks)
- HDL(8 weeks)
- Glucose(8 weeks)
- VCAM-1(8 weeks)
- BMI(8 weeks)
- Triglycerides(8 weeks)
- CRP(8 weeks)
- Oxidized LDL cholesterol(8 weeks)
- MDA(8 weeks)
- TAC(8 weeks)
- Selenium(8 weeks)
- ICAM-1(8 weeks)
- Selenoprotein P(8 weeks)
- IL 10(8 weeks)