NCT00635544已完成不适用
Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
Federico II University8 个研究点 分布在 4 个国家目标入组 80 人开始时间: 2007年1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
- 80
- 试验地点
- 8
- 主要终点
- blood glucose and lipids
研究概览
简要总结
The main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 European centres.
Secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 13-16 yrs
- •Written informed consent
- •Menstrual cycle for at least 6 months
- •Overweight
排除标准
- •Taking part simultaneously in another research trial
- •Involvement in physical training (>4 h/week of vigorous physical activity)
- •Any dietary treatment in the previous two months
- •Body weight changes > 3 kg in the previous two months
- •Gastrointestinal diseases, irritable bowel syndrome, or positive history for recurrent gastrointestinal symptoms such as nausea, vomiting, bloating, epigastric pain, abdominal pain, abdominal discomfort, flatulence, severe constipation
- •Kidney diseases
- •Type 1 or type 2 diabetes
- •Thyroid or other hormonal diseases
- •Other secondary causes (including illnesses) of hyperlipidemia or altered glucose metabolism
- •Severe hyperlipidemia (total cholesterol > 300 mg/dL or triglycerides >300 mg/dL)
- •Severe hypertension
- •Positive history for eating disorders
- •Any regular drug treatment
- •Any food allergy and intolerance
结局指标
主要结局
blood glucose and lipids
时间窗: after 3 weeks of dietary treatment
次要结局
- blood hormones and inflammatory status parameters(after 3 weeks of dietary treatment)
研究者
研究点 (8)
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