Fiber Fermentation Study

NCT ID: NCT04570137

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2020-10-01

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.

Detailed Description

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Conditions

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Intestinal Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two-armed crossover trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

Dietary fiber supplementation

Intervention Type DIETARY_SUPPLEMENT

1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory

2

This arm received the inulin/oligofructose mix first.

Group Type EXPERIMENTAL

Dietary fiber supplementation

Intervention Type DIETARY_SUPPLEMENT

1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory

Interventions

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Dietary fiber supplementation

1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Stephan C. Bischoff, MD, Professor

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan C Bischoff, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim, Institute of Nutritional Medicine

Locations

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Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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FiberStudy

Identifier Type: -

Identifier Source: org_study_id

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