Inulin and the Gut Microbiota in Healthy Adults (INLITE)

Experimental and Clinical Research Center

Status: Completed

Conditions: Gut Microbiota Dysbiosis and Nutrition

Treatments: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05399316

INLITE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Inulin

Active Comparator group

Description:

15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed

Treatment:

Dietary Supplement: Inulin

Maltodextrin

Placebo Comparator group

Description:

15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed

Treatment:

Dietary Supplement: Maltodextrin