Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
研究概览
简要总结
The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.
详细描述
The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •Signed consent prior to any study related procedures
- •Age 18-65 years
- •Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
排除标准
- •Previous complicated gastrointestinal surgery
- •Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
- •Current diagnosis of psychiatric disease
- •Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
- •Systemic use of antibiotics or steroids medications in the last 3 months
- •Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
- •Regular consumption of prebiotic/probiotic products for the past 4 weeks
- •Abuse of alcohol or drugs
- •Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
- •Pregnancy and breast-feeding
结局指标
主要结局
Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) by the end of the in vitro fermentation process.
时间窗: The levels of microbial populations and their metabolic products will be measured at baseline and after 6 hours of in vitro fermentation procedure.
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.
Change from baseline of barrier function after 90 minutes of ex vivo stimulation of the colonic biopsies.
时间窗: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
Barrier function will be evaluated with the use of markers related to paracellular and transcellular permeability, through immunofluoresence and ELISA tecnhique.
次要结局
- Effect of RG-I fractions on immune system reinforcement in the end of the ex vivo stimulation of the colonic biopsies.(Immune system reinforcement will be evaluated after 90 minutes of ex vivo stimulation of the colonic biopsies.)
- Dietary intake prior to the initiation of the study.(Dietary intake will be measured at baseline prior to the initiation of the study as background information.)
- Dietary habits prior to the initiation of the study.(Dietary habits will be measured at baseline prior to the initiation of the study as background information.)
- Gastrointestinal health status prior to the initiation of the study.(Gastrointestinal health will be measured at baseline prior to the initiation of the study as background information.)
研究者
Robert Brummer
Professor
Örebro University, Sweden