NCT05399316

Inulin and the Gut Microbiota in Healthy Adults

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Experimental and Clinical Research Center · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Gut Microbiota Dysbiosis and Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin	Natural fiber supplement extracted from chicory
DIETARY_SUPPLEMENT	Maltodextrin	Natural non-fermentable sugar

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-06-01
• Last updated: 2025-05-02

Locations

1 site across 1 country: Germany