Fiber Fermentation Study

January 7, 2021 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim

Effects Dietary Fiber From Grains or Fruits and Vegetables on the Intestinal Production of Short-chain Fatty Acids

The aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier.

The effect of two different dietary fiber supplements is tested (arabinoxylan & ß-glucan versus inulin & fructooligosaccharides) in a randomized crossover intervention trial including healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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

  • Germany
      • Stuttgart, Germany, 70599
        • Institute of Nutritional Medicine, University of Hohenheim

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 65 years
  • signed written informed consent
  • willingness not to change the dietary pattern in the course of the study

Exclusion Criteria:

  • BMI below 18 or above 30
  • acute or chronic gastrointestinal symptoms
  • neoplastic diseases
  • very strict diets, including raw foodists and frutarians
  • regular smoking (more than one box per day)
  • intake of antibiotics, immunosuppressants, or any intestinal therapeutics three months prior to study begin
  • supplementation of fibers three months prior to study begin
  • simultaneous participation in another clinical study
  • pregnancy / breastfeeding
  • relevant violations of the study protocol
  • intolerance to the fiber supplements (including wheat, oat, chicory)
  • occurrence of relevant diseases (individual decision by study physicians)
  • revocation of consent
  • placement in a clinic or similar facility based on an official or court order

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
This arm received the arabinoxylan/ß-glucan mix first.
Dietary supplement: Dietary fiber supplementation
  1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
  2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory
EXPERIMENTAL: 2
This arm received the inulin/oligofructose mix first.
Dietary supplement: Dietary fiber supplementation
  1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
  2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-chain fatty acids (SCFAs)
Time Frame: Will be measured in approx. 4 weeks after study completion.
SCFAs in native fecal samples
Will be measured in approx. 4 weeks after study completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiome composition
Time Frame: Will be measured in approx. 6-8 weeks after study completion.
16S NGS sequencing
Will be measured in approx. 6-8 weeks after study completion.
Gut barrier integrity
Time Frame: Will be measured in approx. 4 weeks after study completion.
Lipopolysaccharide-binding protein (plasma) and zonulin (feces)
Will be measured in approx. 4 weeks after study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Investigators

  • Principal Investigator: Stephan C Bischoff, Prof., MD, University of Hohenheim, Institute of Nutritional Medicine

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)

July 6, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (ACTUAL)

September 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FiberStudy

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.

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