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临床试验/NCT06528041
NCT06528041招募中不适用

Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals

Purdue University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Changes in Bifidobacterium counts in stool samples

研究概览

简要总结

The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer:

  • To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation.
  • To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation.

The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation.

Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g/day split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g/day split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.

详细描述

The term prebiotic was established in 1995 and has since undergone several updates in definition. As of 2017, the International Scientific Association for Probiotics and Prebiotics (ISAPP) defines prebiotics as a substrates that is selectivity utilised by the host microorganism conferring a health benefit. Of all prebiotics the most highly researched prebiotics are inulin and fructo-oligosaccharides that belong to a group of non-digestible carbohydrates referred to as inulin-type fructans. The main concept behind prebiotics is to stimulate selective changes in microbiota - namely Bifidobacterium in regards to inulin-type fructans. The ability for inulin-type fructans to stimulate changes in bifidobacteria has been demonstrated across across a wide array of studies. Yet, while in vivo studies suggest that inulin-type fructans exert a bifidogenic effect, substantial differences in changes in bifidobacteria responses are often documented between individuals. More specifically, evidence is lacking regarding differences in the rate, extent of change and persistence of the gut microbiota upon the commencement and seizing of inulin supplementation. While, increasing pre-clinical data suggests that a wide variety of bacteria found within the gut can utilise inulin-type fructans in addition to just Bifidobacterium. The aims of this research study are to explore effects that supplementation with 12 g/day inulin-type fructans has on frequent changes in gut microbiota load, composition, gastrointestinal sensation (flatulence, intestinal bloating, abdominal pain and abdominal pressure), bowel habits (stool frequency and stool consistency) and mood with maltodextrin employed as a placebo ((control) 6 g/day). This study will also examine differences in appetite sensation and blood metabolites. The study will consist of 3 phases - a one-week run-in phase; a 6-week supplementation phase and a 6-week post-supplementation phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •adults aged 18-45
  • •BMI >18.5 - < 30 kg/m2
  • •Regular bowel movements (> 4 days per week)

排除标准

  • •Self-reported sensitivity to FODMAPs and following a low FODMAP diet ((FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols).
  • •Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya and lactose etc.
  • •Self-reported antibiotic treatment in the past 6 months.
  • •Self-reported history of gastrointestinal disease and/or heart disease, cardiovascular, liver, and respiratory disorders, cancer and/or clinically relevant (pre) diabetes.
  • •Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.
  • •Self-reported smoking and/or self-reported drug or alcohol abuse.
  • •Self-reported history of psychiatric and/or mood disorders including eating disorders.
  • •Self-reported to be following a restrictive diet (i.e. ketogenic, intermittent fasting).
  • •Pregnant and lactating women.

研究组 & 干预措施

Placebo

Placebo Comparator

6 g/day maltodextrin

干预措施: Maltodextrin (Other)

Pure Inulin

Experimental

12 g/day prebiotic supplement

干预措施: Inulin (Other)

结局指标

主要结局

Changes in Bifidobacterium counts in stool samples

时间窗: 13 weeks

Bifidobacterium counts will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

次要结局

  • Changes in gut bacterial composition(13 weeks)
  • Total bacteria in stool samples(13 weeks)
  • Changes in gut fermentation kinetics(10 days over 13 weeks)
  • Appetite - Feeling of hunger?(12 weeks)
  • Fecal and blood metabolites(12 weeks)
  • Changes in short-chain fatty acid production(10 times over 13 weeks)
  • Gastrointestinal sensations (bloating)(13 week)
  • Appetite - Desire to eat?(12 weeks)
  • Appetite - How strong is your preoccupations with food?(12 weeks)
  • Appetite - Desire to eat something fatty(12 weeks)
  • Stool frequency(13 week)
  • Stool consistency according to Bristol Stool Form Scale(13 week)
  • Gastrointestinal sensations (flatulence)(13 week)
  • Gastrointestinal sensations (abdominal pain)(13 week)
  • Appetite - How much food could you eat right now?(12 weeks)
  • Gastrointestinal sensations (abdominal pressure)(13 week)
  • Appetite - Desire to eat something salty(12 weeks)
  • Appetite - Feeling of Fullness?(12 weeks)
  • Appetite - Feeling of Thirst(12 weeks)
  • Appetite - Desire to eat something sweet(12 weeks)
  • Transient mood(13 weeks)

研究者

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

Stephen R Lindemann, PhD

Associate Professor

Purdue University

研究点 (1)

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