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临床试验/NCT01020617
NCT01020617已完成不适用

Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Microbiota diversity

研究概览

简要总结

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the 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
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 12-15 years
  • IsoBMI>30

排除标准

  • Chronical diseases
  • Chronical medication

结局指标

主要结局

Microbiota diversity

时间窗: one year

Inflammation, CRP

时间窗: 2 months

high sensitive C-reactive protein

次要结局

  • Fecal calprotectin(7 months)
  • Interleukin-6 (Il-6)(one year)
  • Interleukin-10 (IL-10)(one year)
  • Tumor necrosis factor-alpha(TNF-α)(one year)
  • Adiponectin(one year)
  • Leptin(one year)
  • GIP(one year)
  • Antropometry(one year)
  • Blood pressure(one year)
  • Blood lipids(one year)
  • Fasting insulin(one year)
  • Fasting glucose(one year)
  • C-reactive protein (CRP)(6 months)

研究者

申办方类型
Other

研究点 (2)

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