Fiber Fermentation Study

Not Applicable

Completed

• Conditions: Intestinal Health
• Interventions: Dietary Supplement: Dietary fiber supplementation

• Registration Number: NCT04570137
• Lead Sponsor: University of Hohenheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-24
• Primary Completion: 2020-09-30
• Study First Posted: 2020-09-30
• Study Completion: 2020-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Dietary fiber supplementation	This arm received the arabinoxylan/ß-glucan mix first.
2	Dietary fiber supplementation	This arm received the inulin/oligofructose mix first.

Primary Outcome Measures

Name	Time	Method
Short-chain fatty acids (SCFAs)	Will be measured in approx. 4 weeks after study completion.	SCFAs in native fecal samples

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Nutritional Medicine, University of Hohenheim; 🇩🇪 Stuttgart, Germany