Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
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
- 是
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
Arne Astrup
MD, Professor
University of Copenhagen
