Gut Microbiota Dysbiosis and Nutrition
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInulin
Natural fiber supplement extracted from chicory
DIETARY_SUPPLEMENTMaltodextrin
Natural non-fermentable sugar
Sponsors
Experimental and Clinical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants and study staff are blinded
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| serum butyrate | 12 months | the change in butyrate measured in serum |
Countries
Germany
Outcome results
None listed