Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Remission of metabolic syndrome.
研究概览
简要总结
The metabolic syndrome consists of a set of risk factors that increases the probability to develop heart diseases and type 2 diabetes, two of the principal chronic diseases that affect Mexican population. The curcumin is a compound that is extracted from the root of a plant called Cúrcuma longa. There exists information that curcumin helps to diminish weight and the levels of blood glucose and blood fats. The hypothesis of this study is: that curcumin administration combined with diet and exercise remits the metabolic syndrome.
详细描述
Objective: The aim of this study is to determinate the efficacy of oral administration of curcumin in the remission of metabolic syndrome.
Design: clinical trial, randomized, double blind, placebo controlled.
Study population: Men and women from 20 to 55 years old with metabolic syndrome according to the ATP III criteria, will be included.
Study groups: intervention and control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05. A 50% of the difference in the mean of remission of metabolic syndrome between control group and intervention groups was considered. The estimated sample size was 220 subjects for each group.
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)
盲法说明
Neither the patient nor the treating doctor will know the study group the participant was randomized.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men.
- •20 to 55 years old.
- •Diagnosis of metabolic syndrome according to the ATP III criteria.
- •Informed consent of the participant.
排除标准
- •Diabetes or hypoglycaemic therapy.
- •High blood pressure o anti-hypertensive treatments.
- •Hypertriglyceridemia (>400 g/dL) or lipid lowering treatment.
- •Neoplasia disease.
- •Thyroid disease
- •Syndrome of polycystic ovary.
- •Pregnancy or lactation.
- •Anti-inflammatory medicines in the last two months.
- •Food supplements in the last two months.
结局指标
主要结局
Remission of metabolic syndrome.
时间窗: Three months.
Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.
次要结局
未报告次要终点
研究者
Fernando Guerrero Romero MD
Head of the research unit
Coordinación de Investigación en Salud, Mexico