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Inulin and the Gut Microbiota in Healthy Adults (INLITE)

Primary Purpose

Gut Microbiota Dysbiosis and Nutrition

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Inulin
Maltodextrin
Sponsored by
Experimental and Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gut Microbiota Dysbiosis and Nutrition

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Experimental and Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Inulin

Maltodextrin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

serum butyrate
the change in butyrate measured in serum

Full Information

First Posted
May 5, 2022
Last Updated
May 30, 2022
Sponsor
Experimental and Clinical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05399316
Brief Title
Inulin and the Gut Microbiota in Healthy Adults
Acronym
INLITE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Experimental and Clinical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota Dysbiosis and Nutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All participants and study staff are blinded
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inulin
Arm Type
Active Comparator
Arm Description
15g of powdered inulin is given in a sachet. The powder is dissolved in water and consumed
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
15g of powdered maltodextrin is given in a sachet. The powder is dissolved in water and consumed
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
Natural fiber supplement extracted from chicory
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Natural non-fermentable sugar
Primary Outcome Measure Information:
Title
Metabolite associated bacterial gene expression
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
serum butyrate
Description
the change in butyrate measured in serum
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Wilck, MD
Organizational Affiliation
Charite University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik Bartolomaeus, MD
Organizational Affiliation
Charite University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria McParland, PhD
Organizational Affiliation
ECRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Experimental and Clinical Research Center
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Inulin and the Gut Microbiota in Healthy Adults

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