Inulin and the Gut Microbiota in Healthy Adults (INLITE)
April 29, 2025 updated by: Victoria McParland, Experimental and Clinical Research Center
The Effect of the Prebiotic Fiber INulin on metaboLITE Production of the Gut Microbiota in Healthy Adults- a Randomized, Double Blind Placebo-controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 13125
- Experimental and Clinical Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 56 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Inulin
15g of powdered inulin is given in a sachet.
The powder is dissolved in water and consumed
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Natural fiber supplement extracted from chicory
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Placebo Comparator: Maltodextrin
15g of powdered maltodextrin is given in a sachet.
The powder is dissolved in water and consumed
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Natural non-fermentable sugar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolite associated bacterial gene expression
Time Frame: 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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum butyrate
Time Frame: 12 months
|
the change in butyrate measured in serum
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicola Wilck, MD, Charite University
- Principal Investigator: Hendrik Bartolomaeus, MD, Charite University
- Principal Investigator: Victoria McParland, PhD, ECRC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
May 2, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INLITE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.