Inulin and the Gut Microbiota in Healthy Adults

NCT ID: NCT05399316

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-12-31

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.

Conditions

Gut Microbiota Dysbiosis and Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Inulin

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

Group Type: ACTIVE_COMPARATOR

Inulin

Intervention Type: DIETARY_SUPPLEMENT

Natural fiber supplement extracted from chicory

Maltodextrin

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

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Natural non-fermentable sugar

Interventions

Inulin

Natural fiber supplement extracted from chicory

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Natural non-fermentable sugar

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Experimental and Clinical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Victoria McParland

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Wilck, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University

Hendrik Bartolomaeus, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University

Victoria McParland, PhD

Role: PRINCIPAL_INVESTIGATOR

ECRC

Locations

Experimental and Clinical Research Center

Berlin, , Germany

Countries

Germany

Other Identifiers

INLITE

Identifier Type: -

Identifier Source: org_study_id