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临床试验/NCT01433120
NCT01433120已完成不适用

Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年9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
58
试验地点
2
主要终点
Insulin resistance

研究概览

简要总结

Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances.

The objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome.

The study is based on the following hypotheses:

  • Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo.
  • The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).

After completion of the dietary intervention, the participants are offered a 10-week weight reduction program. Those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Post-menopausal
  • BMI between 30-45 kg/m2
  • Waist circumference > 80 cm
  • High leukocyte count

排除标准

  • Medically-treated Type 2 diabetes or dyslipidaemia
  • Use of antibiotics during the last 3 months
  • Use of pro- or prebiotic supplements during the last 6 weeks
  • Illnesses related to the gastro-intestinal tract
  • History of psychiatric diseases (incl. depression)
  • Liver disease
  • Alcohol abuse

结局指标

主要结局

Insulin resistance

时间窗: Week 0,6

3H OGTT (75g glucose)

Changes in the gut microbiota

时间窗: Week 0,6

次要结局

  • Lipid metabolism(Week 0,6)
  • Inflammatory markers(Week 0,4,6)
  • Total fat mass and abdominal fat(Week 0,6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne Astrup

MD, Professor

University of Copenhagen

研究点 (2)

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