NCT01223989已完成4 期
Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz0 个研究点目标入组 122 人开始时间: 2009年3月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- changes in anthropometric parameters
研究概览
简要总结
The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •sex female
- •signed informed consent
- •patient with overweight and obesity (IMC: > 25 < 39.9)
排除标准
- •Family and social environment that prevents compliance with treatment diet.
- •Having to perform any kind of diet special sickness associated: Celiac disease, chronic renal failure, etc.
- •patients with Diabetes Mellitus.
- •patients with Eating disorders.
- •patients with Dementia, Mental illness or impaired function cognitive.
- •consuming drugs or substances for losing weight (except in those cases in which suspension thereof 15 days of beginning the study).
- •Present disease which may interfere with weight loss: serious psychiatric disease, hypothyroidism not controlled.
- •Be pregnant or period of lactation.
- •Inability to comply with the physical activity plan agreed.
- •Want to quit smoking during the time that lasts for the study.
结局指标
主要结局
changes in anthropometric parameters
时间窗: after 16 weeks of start the diet
weight, height, BMI, fat mass, lean mass.
次要结局
- Adherence(after 16 weeks of start the diet)
- changes in biochemical parameters(after 16 weeks of start the diet)
- change in satiety and hunger Test(after 16 weeks of start the diet)
研究者
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