Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on the Lipid Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Cholesterol LDL
研究概览
简要总结
The aim of this clinical trial is to evaluate the functionality of an extract rich in phytosterols and phytostanols on parameters related to the lipid profile of individuals with hypercholesterolemia, mainly on total cholesterol and LDL cholesterol levels
详细描述
A total of 45 participants with hypercholesterolemia (total cholesterol>200 mg/dL) will be recruited. Participants must not be taking any medication or nutritional supplement aimed at lowering cholesterol levels. Social networks and advertisements at the Universidad Católica San Antonio de Murcia (UCAM) and the Centro de Edafología y Biología Aplicada del Segura (CEBAS) will be used to recruit the individuals.
First, participants will attend to an informative session to learn in more detail about the objectives of the study and the procedures to be followed. In this session participants will sign the informed consent.
They will be divided into two groups:
- One group (n=23) that will take an extract rich in phytosterols and phytostanols (mainly β-sitosterol, β-sitostanol, campesterol and stigmasterol), resveratrol and hydroxytyrosol. The extract will be taken in capsule format.
- A control group (n=22) that will take a placebo supplement.
At the beginning of the study, anthropometric measurements of the participants will be taken. The participants' blood pressure will also be measured. An interview-questionnaire will be conducted to learn about and evaluate participants´s diet, physical activity and sleep quality. A blood sample will also be taken from the participants for biochemical analysis (total cholesterol, HDL, LDL, oxidized LDL, triglycerides and transaminases). From this day on, all participants will take two capsules daily of the phytosterol-rich extract or the placebo capsule, as appropriate, for 56 days. Capsules will be taken at night after dinner. Sampling and biochemical analysis will be repeated on days 28 and 56.
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
- Double (Participant, Investigator)
盲法说明
Clinical trial organizer (Universidad Católica San Antonio de Murcia, UCAM)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total cholesterol>=200 mg/dl -
排除标准
- •total cholesterol<200 mg/dl
结局指标
主要结局
Cholesterol LDL
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in cholesterol LDL levels measured at 28 and 56 days
Cholesterol HDL
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in cholesterol HDL levels measured at 28 and 56 days
Oxidized LDL
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in oxidized LDL levels measured at 28 and 56 days
Transaminase
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in transaminase levels measured at 28 days and 56 days
Total cholesterol
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in total cholesterol levels measured at 28 and 56 days
Triglyceride
时间窗: From enrollment to the end of treatment at 56 days
Change from baseline in triglyceride levels measured at 28 days and 56 days
次要结局
未报告次要终点
研究者
Francisco A. Tomás-Barberán
Research Professor
Centro de Edafología y Biología Aplicada del Segura
