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
干预措施
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
研究组 & 干预措施
Phytosterol
Experimental
Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
干预措施: Phytosterols (Dietary Supplement)
Placebo
Placebo Comparator
Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.
干预措施: Titanium Dioxide (Dietary Supplement)
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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