Inulin and the Gut Microbiota in Healthy Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of the Prebiotic Fiber INulin on metaboLITE Production of the Gut Microbiota in Healthy Adults- a Randomized, Double Blind Placebo-controlled Study

Conditions
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Gut Microbiota Dysbiosis and Nutrition

Intervention / Treatment
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* Dietary Supplement: Inulin
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women in a 1:1 ratio Age 20 - 60 years Body Mass Index 18.5 - 34.9 kg/m2 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inulin<br>15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed | Dietary Supplement: Inulin<br>* Natural fiber supplement extracted from chicory<br>|
| Placebo Comparator: Maltodextrin<br>15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed | Dietary Supplement: Maltodextrin<br>* Natural non-fermentable sugar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite associated bacterial gene expression | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum butyrate | the change in butyrate measured in serum | 12 months |