Fiber Fermentation Study

Intestinal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570137
• Other study ID #: FiberStudy
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Health

Intervention

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

Locations

Country	Name	City	State
Germany	Institute of Nutritional Medicine, University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-chain fatty acids (SCFAs)	SCFAs in native fecal samples	Will be measured in approx. 4 weeks after study completion.
Secondary	Gut microbiome composition	16S NGS sequencing	Will be measured in approx. 6-8 weeks after study completion.
Secondary	Gut barrier integrity	Lipopolysaccharide-binding protein (plasma) and zonulin (feces)	Will be measured in approx. 4 weeks after study completion.