Inulin and the Gut Microbiota in Healthy Adults

Not Applicable

Completed

• Conditions: Gut Microbiota Dysbiosis and Nutrition
• Interventions: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

• Registration Number: NCT05399316
• Lead Sponsor: Experimental and Clinical Research Center

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-01
• Study Start: 2022-06-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inulin	Inulin	15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed
Maltodextrin	Maltodextrin	15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed

Primary Outcome Measures

Name	Time	Method
Metabolite associated bacterial gene expression	12 months	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).

Secondary Outcome Measures

Name	Time	Method
serum butyrate	12 months	the change in butyrate measured in serum

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany