Fiber Fermentation Study

NCT04570137 | Completed

• 1 other identifier: FiberStudy
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Health

Keywords

Gastroenterology; Gut microbiome; Gut barrier

Outcome Measures

Primary Outcomes (1)

• Short-chain fatty acids (SCFAs)

  SCFAs in native fecal samples

  Will be measured in approx. 4 weeks after study completion.

Secondary Outcomes (2)

• Gut microbiome composition

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

• Gut barrier integrity

  Will be measured in approx. 4 weeks after study completion.

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Dietary fiber supplementation

2

EXPERIMENTAL

This arm received the inulin/oligofructose mix first.

Dietary Supplement: Dietary fiber supplementation

Interventions

Dietary fiber supplementation 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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years
• signed written informed consent
• willingness not to change the dietary pattern in the course of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hohenheim: lead

Study Sites (1)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

Location

Study Officials

• Stephan C Bischoff, Prof., MD

  University of Hohenheim, Institute of Nutritional Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Two-armed crossover trial

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 30, 2020
• Study Start: July 6, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 1, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)