The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Frederiksberg、丹麦、1958
- Copenhagen University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 12-15 years
- IsoBMI>30
Exclusion Criteria:
- Chronical diseases
- Chronical medication
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Microbiota diversity
大体时间:one year
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one year
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Inflammation, CRP
大体时间:2 months
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high sensitive C-reactive protein
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2 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
Antropometry
大体时间:one year
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one year
|
血压
大体时间:一年
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一年
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Blood lipids
大体时间:one year
|
one year
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Fasting insulin
大体时间:one year
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one year
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Fasting glucose
大体时间:one year
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one year
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C-reactive protein (CRP)
大体时间:6 months
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6 months
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Fecal calprotectin
大体时间:7 months
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7 months
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Interleukin-6 (Il-6)
大体时间:one year
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one year
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Interleukin-10 (IL-10)
大体时间:one year
|
one year
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Tumor necrosis factor-alpha(TNF-α)
大体时间:one year
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one year
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Adiponectin
大体时间:one year
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one year
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Leptin
大体时间:one year
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one year
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GIP
大体时间:one year
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one year
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合作者和调查者
调查人员
- 首席研究员:Kim F Michaelsen, Professor、University of Copenhagen, Department of Human Nutrition
出版物和有用的链接
一般刊物
- Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.
- Giacco R, Lappi J, Costabile G, Kolehmainen M, Schwab U, Landberg R, Uusitupa M, Poutanen K, Pacini G, Rivellese AA, Riccardi G, Mykkanen H. Effects of rye and whole wheat versus refined cereal foods on metabolic risk factors: a randomised controlled two-centre intervention study. Clin Nutr. 2013 Dec;32(6):941-9. doi: 10.1016/j.clnu.2013.01.016. Epub 2013 Feb 6.
- Gobel RJ, Larsen N, Jakobsen M, Molgaard C, Michaelsen KF. Probiotics to adolescents with obesity: effects on inflammation and metabolic syndrome. J Pediatr Gastroenterol Nutr. 2012 Dec;55(6):673-8. doi: 10.1097/MPG.0b013e318263066c.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Ls-33的临床试验
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