Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome (FRUCTOB)
Obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... Some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation.
In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al, Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in healthy human. An intervention study in obese patients is thus needed to study the effects of fructans in the target population.
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
-
-
Branbant Wallon
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Bruxelles、Branbant Wallon、比利时、1200
- Cliniques Universitaires Saint Luc
-
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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:
- BMI>30 kg/m2
Exclusion Criteria:
- acute or chronic evoluting disease
- alcohol consumption > 30 units/week
- more than 30 minutes of sports 3 times/week
- usual consumption of pre/probiotics or fibers supplement
- recent consumption of antibiotics
- slimming diet or unusual diet
- pregnant women
- anti-diabetics drugs ou slimming drugs
- previous bariatric surgery
- severe oesophagus reflux
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:B
Maltodextrin, non digestible carbohydrate
|
8 grams/day during the first week and then 8 grams twice a day during 3 months
|
|
实验性的:A
fructans, non digestible carbohydrates fermented in the caeco-colon
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8 grams/day during the first week and then 8 grams twice a day during 3 months
其他名称:
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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 |
|---|---|---|
|
gut microbiota composition
大体时间:3 months
|
HITChip analysis (phylogenetic profiling by DNA microarray)
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
gut microbial-related metabolites (in urine and plasma)
大体时间:3 months
|
NMR spectroscopic analysis of urine and plasma metabolic profiles
|
3 months
|
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metabolic parameters (weight, BMI, glycemia, fat mass,...)
大体时间:3 months
|
3 months
|
合作者和调查者
调查人员
- 首席研究员:Thissen Jean-Paul、Cliniques universitaires Saint-Luc- Université Catholique de Louvain
出版物和有用的链接
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
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