The Effect of the Prebiotic Fiber INulin on metaboLITE Production of the Gut Microbiota in Healthy Adults- a Randomized, Double Blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Metabolite associated bacterial gene expression
研究概览
简要总结
In this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. For this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. The main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.
详细描述
Healthy volunteers between the age of 18 and 60 will be recruited. In the first week of the study baseline blood and stool sampleswill be collected and nutritional information recorded. The participants will then take 15g of inulin or maltodextrin twice per day for 14 consequetive days. Blood and stool samples will be collected daily during the inital phase of the intervention and again at the end of the intervention.
From the stool samples bacterial nucleic acids will be isolated and used for metagenomic and transcriptomic analysis. The blood samples will be used to analyse for markers of barriere function and for analysis of immune cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants and study staff are blinded
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women in a 1:1 ratio
- •Age 20 - 60 years
- •Body Mass Index 18.5 - 34.9 kg/m2
排除标准
- •Arterial hypertension, diabetes mellitus, known cardiovascular disease requiring treatment (e.g. coronary heart disease, stroke).
- •Known end-organ damage to the brain, heart or kidneys
- •Chronic kidney disease, need for dialysis
- •Diseases or functional disorders that, in the opinion of the study doctor, preclude participation in the study
- •Acute infections
- •Malnutrition
- •Antibiotics in the previous 4 weeks
- •Regular consumption of probiotics or prebiotics
- •Allergies
- •Change in bodyweight of more than 2 kg in the previous 3 months
- •Inability to uderstand the studie aims and study procedures
- •Drug or alcohol abuse
结局指标
主要结局
Metabolite associated bacterial gene expression
时间窗: 12 months
The change in bacterial expression of butyrate- and propionate-associated genes in stool samples compared to placebo, adjusted to baseline. The expression of butyrate- and propionate-associated genes is measured in stool samples by quantitative PCR (qPCR).
次要结局
- serum butyrate(12 months)
研究者
Victoria McParland
Principal Investigator
Experimental and Clinical Research Center