NCT00924274Unknown不适用
Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
研究概览
简要总结
Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chilren and adolescents between 6 and 18 years of age
- •LDLc > 130 mg/dl and
- •TC > 200 mg/dl
- •7 day nutrition record
- •written informed consent
排除标准
- •overweight
- •underweight
- •mental disability
- •drug therapy
结局指标
主要结局
Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
时间窗: done in Week 1, Week 7, Week 13
次要结局
- Motivation, compliance, increase of quality of life.(done in Week 1 and Week 13)
- Acceptance and approach to the disease.(done in Week 1 and Week 13)
- Improvement of knowledge and understanding about the disease by the patients.(done in Week 1 and Week 13)
研究者
研究点 (2)
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