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OpenTrials
Completed

NCT Number: NCT05399316

Inulin and the Gut Microbiota in Healthy Adults

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental and Clinical Research Center

Berlin, 13125, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin

Dietary Supplement

Natural fiber supplement extracted from chicory

Maltodextrin

Dietary Supplement

Natural non-fermentable sugar

Primary outcomes

  1. 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).

Secondary outcomes

  1. serum butyrate

    Time frame: 12 months

    the change in butyrate measured in serum

Sponsors and collaborators

Lead sponsor

Experimental and Clinical Research Center

Other

Registry information

Official study 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

Acronym: INLITE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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