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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin | Active Comparator | 15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed |
|
| Maltodextrin | Placebo Comparator | 15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | Natural fiber supplement extracted from chicory |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| serum butyrate | the change in butyrate measured in serum | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Wilck, MD | Charite University | Principal Investigator |
| Hendrik Bartolomaeus, MD | Charite University | Principal Investigator |
| Victoria McParland, PhD | ECRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Research Center | Berlin | 13125 | Germany |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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All participants and study staff are blinded
| Maltodextrin |
| Dietary Supplement |
Natural non-fermentable sugar |
|
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |