Gut Microbiota Dysbiosis and NutritionINLITENCT05399316
Inulin and the Gut Microbiota in Healthy Adults
A study testing Inulin and Maltodextrin in people with Gut Microbiota Dysbiosis and Nutrition, run by Experimental and Clinical Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota Dysbiosis and Nutrition
- What is being tested?
- Inulin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women in a 1:1 ratio
- Age 20 - 60 years
- Body Mass Index 18.5 - 34.9 kg/m2
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Inulin, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Natural fiber supplement extracted from chicory
MaltodextrinDietary supplement
Natural non-fermentable sugar
| Study group | Role | What they receive |
|---|---|---|
| Inulin | Active comparator | 15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed Receives: Dietary Supplement: Inulin |
| Maltodextrin | Placebo comparator | 15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
serum butyrate
the change in butyrate measured in serum
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Microbiota Dysbiosis and NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Experimental and Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria McParland, Experimental and Clinical Research Center
- Investigators
- Nicola Wilck, MD, Principal investigator, Charite UniversityHendrik Bartolomaeus, MD, Principal investigator, Charite UniversityVictoria McParland, PhD, Principal investigator, ECRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399316
- Sponsor's protocol ID
- INLITE
- Acronym
- INLITE
- Status last verified
- Apr 2025
- First submitted
- 5 May 2022
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Prebiotic Fiber INulin on metaboLITE Production of the Gut Microbiota in Healthy Adults- a Randomized, Double Blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05399316
- Acronym / sponsor ID
- INLITE / INLITE
- Conditions
- Gut Microbiota Dysbiosis and Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Experimental and Clinical Research CenterUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inulin | Active comparator | Dietary Supplement: Inulin15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women in a 1:1 ratio
- Age 20 - 60 years
- Body Mass Index 18.5 - 34.9 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinNatural fiber supplement extracted from chicory | Dietary supplement | Inulin |
| MaltodextrinNatural non-fermentable sugar | Dietary supplement | Maltodextrin |
Primary outcome
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).
1 secondary outcome
serum butyrate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Wilck, MD principal investigator
Charite University
Hendrik Bartolomaeus, MD principal investigator
Charite University
Victoria McParland, PhD principal investigator
ECRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin and Maltodextrin in people with Gut Microbiota Dysbiosis and Nutrition, run by Experimental and Clinical Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolite associated bacterial gene expression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.