Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Change in total and LDL-cholesterol
研究概览
简要总结
The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects.
The main questions it aims to answer are:
- do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?
- do phytosterols modify the quality of LDL?
Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.
详细描述
Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.
Study was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.
Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.
HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).
Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •participants of both sexes, aged >18 and <65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and <190 mg/dL and triglycerides <400 mg/dL.
排除标准
- •secondary causes of dyslipidemia, renal (creatinine > 2mg/dL), hepatic (AST or ALT > 1.5 ULN), or metabolic (HbA1c >8.0%) dysfunction, with BMI <18.5 or >40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols
结局指标
主要结局
Change in total and LDL-cholesterol
时间窗: 12 weeks
Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol
次要结局
- Change in LDL subfractions(12 weeks)
- Change in HDL subfractions(12 weeks)
- Improvement on quality of LDL particle(12 weeks)
研究者
Maria Cristina de Oliveira Izar
Assistant Professor of Medicine
Federal University of São Paulo