Isafruit: Nutrigenomics in Overweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
研究概览
简要总结
The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI over 30
- •No daily medication
- •Not strenuous exercise > 10hours/week
- •No blood donation 3 months before or during the study
排除标准
- •Simultaneous participation in other research projects
- •Use of any dietary supplements
结局指标
主要结局
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
时间窗: Measured at week 6
次要结局
- Inflammatory marker (hs-CRP)(Measured at week 6)
- Gene expression in white blood cells and colon tissue(Measured at week 6)
- Enzyme activity in lysed erythrocytes (glutathione peroxidase)(Measured at week 6)
- Blood pressure(Measured at week 6)
- Anthropometry (weight, height, waist and hip circumference)(Measured at week 6)
- Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)(Measured at week 6)
- Urine analyses (metabolomics)(Measured at week 6)
- Serum insulin, IGF-1 and IGFBP-3 levels(Measured at week 6)
研究者
Arne Astrup
professor
University of Copenhagen