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Completed

NCT Number: NCT04570137

Fiber Fermentation Study

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.

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Key information

Conditions

Intestinal Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dietary Fiber Supplementation

Dietary Supplement
  • 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

Primary outcomes

  1. Short-chain fatty acids (SCFAs)

    Time frame: Will be measured in approx. 4 weeks after study completion.

    SCFAs in native fecal samples

Secondary outcomes

  1. Gut microbiome composition

    Time frame: Will be measured in approx. 6-8 weeks after study completion.

    16S NGS sequencing

  2. Gut barrier integrity

    Time frame: Will be measured in approx. 4 weeks after study completion.

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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2020
Registry last updated
Jan 8, 2021

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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