Fiber Fermentation Study

Sponsor
University of Hohenheim (Other)
Overall Status
Completed
CT.gov ID
NCT04570137
Collaborator
(none)
21
1
2
2.9
7.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary fiber supplementation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Two-armed crossover trialTwo-armed crossover trial
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effects Dietary Fiber From Grains or Fruits and Vegetables on the Intestinal Production of Short-chain Fatty Acids
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

This arm received the arabinoxylan/ß-glucan mix first.

Dietary Supplement: Dietary fiber supplementation
16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan) 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
16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan) 16g/day: mix of 50% inulin and 50% oligofructose from chicory

Outcome Measures

Primary Outcome Measures

  1. Short-chain fatty acids (SCFAs) [Will be measured in approx. 4 weeks after study completion.]

    SCFAs in native fecal samples

Secondary Outcome Measures

  1. Gut microbiome composition [Will be measured in approx. 6-8 weeks after study completion.]

    16S NGS sequencing

  2. Gut barrier integrity [Will be measured in approx. 4 weeks after study completion.]

    Lipopolysaccharide-binding protein (plasma) and zonulin (feces)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Nutritional Medicine, University of Hohenheim Stuttgart Germany 70599

Sponsors and Collaborators

  • University of Hohenheim

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephan C. Bischoff, MD, Professor, Prof. Dr., University of Hohenheim
ClinicalTrials.gov Identifier:
NCT04570137
Other Study ID Numbers:
  • FiberStudy
First Posted:
Sep 30, 2020
Last Update Posted:
Jan 8, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephan C. Bischoff, MD, Professor, Prof. Dr., University of Hohenheim

Study Results

No Results Posted as of Jan 8, 2021