NCT01184963已完成不适用
Effect of High-protein or Normal-protein Diet on Weight Loss, Body Composition, Hormone and Metabolic Profile in Women With Polycystic Ovary Syndrome From South Brazil: A Randomized Study
Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in corporal weight
研究概览
简要总结
The objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.
Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.
The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and 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
- None
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women of reproductive age
- •BMI ranging from 18.5 to 39.9 kg/m²
排除标准
- •Use of any drugs known to interfere with hormone levels for at least 3 months before the study
- •Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
- •Other hyperandrogenic disorders than PCOS
结局指标
主要结局
Changes in corporal weight
时间窗: 8 weeks
次要结局
- Changes in body composition(8 weeks)
- changes in hormone and metabolic profile.(8 weeks)
研究者
研究点 (2)
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