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
- 81
- 试验地点
- 2
- 主要终点
- Change from baseline to the effect on selected intestinal microbial populations.
研究概览
简要总结
The aim of this study is to determine, quantify and understand the potential prebiotic effects of RG-I variants via microbiota modulation. The anti-inflammatory potential effects of these variants will also be investigated.
详细描述
The plant cell wall derived RG-I (from chicory or carrot) and maltodextrin (placebo) in capsuled form will be provided by the food company NutriLeads B.V (Wageningen, The Netherlands), which has run tests of safety of the products and warranties their food grade quality and safety. The administration of RG-I will be done via a human intervention study of parallel arms, randomized, placebo - controlled, double blinded design (proof of concept study).
The dietary fibre from different RG-I sources will be tested for its prebiotic and immunomodulatory potential. Thus, the effects of these fibres on short chain fatty acid (SCFA) profile, microbiota composition, microbiota-associated metabolites and intestinal inflammatory markers will be investigated from fecal material obtained from the study participants.
The dietary fibre from different RG-I sources will be tested for their immunomodulatory and lifestyle related effects. The effects of fibres on immune activation markers will be investigated from blood samples collected from the study participants.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 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 18-70 years
- •Willing to abstain from regular consumption of prebiotics/probiotics/synbiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
- •Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg m-2
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. Inflammatory Bowel Disease)
- •Systemic use of antibiotics or steroids medications in the last 3 months prior to study visits
- •Frequent use of NSAID (Non-Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
- •Abuse of alcohol or drugs
- •Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 3 months prior to study visits
- •Pregnancy and breast-feeding
- •Vegan dietary habits or consumption of dietary fibers ≥ 25 g per day according to the food frequency questionnaire
- •Smoking or usage of snus within last 3 months prior to study visits
- •No recent weight loss or gain 5% of their normal weight in the last month
结局指标
主要结局
Change from baseline to the effect on selected intestinal microbial populations.
时间窗: The levels of the selected microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
Selected microbial populations will be quantified with quantitative Polymerase Chain Reaction (PCR).
Change from baseline to the effect on the intestinal microbial populations.
时间窗: The levels of the microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period)
Microbial populations will be quantified with 16SRNA sequencing.
次要结局
- Change from baseline to the effect on exhaled volatile organic compounds levels.(Exhaled volatile organic compounds levels will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Gastrointestinal tolerance of the supplement.(Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Change from baseline to the effect on the intestinal microbial populations's metabolic products [i.e. Short-Chain Fatty Acids (SCFA)].(SCFAs levels will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Change from baseline to the effect on inflammation.(Inflammation will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Changes from baseline to the effect on physical activity levels.(Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Change from baseline to the effect on immune system reinforcement.(Immune system reinforcement will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- Change from baseline to the effect on fecal metabolomic fingerprinting.(Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period))
- 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.)
- Changes from baseline to the effect on quality of life.(Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period))
研究者
Robert Brummer
Professor
Örebro University, Sweden