Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- gut microbiota composition
研究概览
简要总结
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI>30 kg/m2
排除标准
- •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
结局指标
主要结局
gut microbiota composition
时间窗: 3 months
HITChip analysis (phylogenetic profiling by DNA microarray)
次要结局
- gut microbial-related metabolites (in urine and plasma)(3 months)
- metabolic parameters (weight, BMI, glycemia, fat mass,...)(3 months)