NCT02969720已完成不适用
Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
研究概览
简要总结
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.
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, Care Provider)
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
- 否
入选标准
- •Informed consent written
- •Available subjects to follow-up visits
- •Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria
- •Subjects with health visits ongoing
- •Subjects with arterial hypertension under control.
- •Subjects with mellitus diabetes under control.
排除标准
- •Subjects with alcoholism history.
- •Subjects with history of sitosterolemia.
- •Subjects with familiar hypercholesterolemia
- •Subjects who are consuming phytosterols
- •Pregnancy women
- •Breastfeeding period women
- •Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation
结局指标
主要结局
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
时间窗: 180 days
次要结局
未报告次要终点
研究者
Yasna Palmeiro-Silva
Asistant Professor
Universidad de los Andes, Chile
研究点 (1)
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