Inulin and the Gut Microbiota in Healthy Adults

NCT05399316 | Completed

• 1 other identifier: INLITE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota Dysbiosis and Nutrition

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (1)

• serum butyrate

  12 months

Study Arms (2)

Inulin

ACTIVE COMPARATOR

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

Dietary Supplement: Inulin

Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

Inulin DIETARY_SUPPLEMENT

Natural fiber supplement extracted from chicory

Inulin

Maltodextrin DIETARY_SUPPLEMENT

Natural non-fermentable sugar

Maltodextrin

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women in a 1:1 ratio
• Age 20 - 60 years
• Body Mass Index 18.5 - 34.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Experimental and Clinical Research Center: lead

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

Location

MeSH Terms

Interventions

Inulin; maltodextrin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Nicola Wilck, MD

  Charite University

  PRINCIPAL INVESTIGATOR

• Hendrik Bartolomaeus, MD

  Charite University

  PRINCIPAL INVESTIGATOR

• Victoria McParland, PhD

  ECRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and study staff are blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 1, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)