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临床试验/NCT01004120
NCT01004120已完成1 期

Double-blind, Placebo Controlled, Randomised, Cross-over Study to Determine the Effect of a Prebiotic Galactooligosaccharide on Microbiota and Metabolic Syndrome Risk Factors in Overweight Adults

Clasado2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.

研究概览

简要总结

The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic factors. However, recent observations have involved gut microbiota profiles as having an additional influence. In this case, there exists the possibility to modulate this through diet. Research has shown that the gut microbiota of both obese humans and mouse models of obesity is altered towards less beneficial one compared to lean counterparts. This raises the possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of obesity and diabetes sweeping the developed world. In addition, a more direct effect of high-fat induced disruption of the intestinal microbiota has also been seen with a murine model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation, termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that increase the risk of developing cardiovascular disease and diabetes) in overweight adults have not been investigated thus far. The investigators therefore propose to investigate the effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI >25 kg/m2

排除标准

  • Suffered from a myocardial infarction/stroke or cancer in the past 12 months
  • Diabetic or suffering from endocrine disorders
  • Suffer from renal or bowel disease/gut disorder or have a history of cholestatic jaundice or pancreatitis
  • Requirements to take long-term medication for hyperlipidaemia, hypertension, inflammation or hypercoagulation
  • History of alcohol or drug abuse
  • Planning or on a weight reducing regime
  • Taking antioxidant (or phytochemical), probiotic or prebiotics supplements
  • Pregnant or lactating women or those planning pregnancy in the next 6 months or of child-bearing age who are not using contraception
  • Use of antibiotics within the previous 1 month

结局指标

主要结局

Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.

时间窗: 3 months

Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)

时间窗: 3 months

Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)

时间窗: 3 months

次要结局

  • Insulin resistance derived from fasted measures of glucose and insulin ratio(3 months)

研究者

发起方
Clasado
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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