Fiber Fermentation Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Intestinal Health

Intervention / Treatment
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* Dietary Supplement: Dietary fiber supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two-armed crossover trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This arm received the arabinoxylan/ß-glucan mix first. | Dietary Supplement: Dietary fiber supplementation<br>* 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<br>|
| Experimental: 2<br>This arm received the inulin/oligofructose mix first. | Dietary Supplement: Dietary fiber supplementation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-chain fatty acids (SCFAs) | 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 | 16S NGS sequencing | Will be measured in approx. 6-8 weeks after study completion. | 
| Gut barrier integrity | Lipopolysaccharide-binding protein (plasma) and zonulin (feces) | Will be measured in approx. 4 weeks after study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterology, Gut microbiome, Gut barrier