Inulin and the Gut Microbiota in Healthy Adults

Experimental and Clinical Research Center24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Gut Microbiota Dysbiosis and Nutrition

Interventions

InulinDIETARY_SUPPLEMENT

Natural fiber supplement extracted from chicory

MaltodextrinDIETARY_SUPPLEMENT

Natural non-fermentable sugar

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Experimental and Clinical Research Center

Berlin, Germany

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Secondary Outcomes

serum butyrate

the change in butyrate measured in serum

Time frame: 12 months

Data from ClinicalTrials.gov

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