Cereals and Intestinal Function

Sponsor

University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT04019457

Collaborator

(none)

Enrollment

Location

Arms

18.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Endotoxemia Diet, Healthy	Other: Dietary intervention	N/A

Detailed Description

In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Cereals and Intestinal Function: Investigations in Healthy Participants

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary fiber 1 Participants receive cereal flakes 1 to include it in their normal diet.	Other: Dietary intervention Dietary intervention: Participants receive dietary fibers for a defined number of days.
Experimental: Dietary fiber 2 Participants receive cereal flakes 2 to include it in their normal diet.	Other: Dietary intervention Dietary intervention: Participants receive dietary fibers for a defined number of days.

Arm

Intervention/Treatment

Experimental: Dietary fiber 1

Participants receive cereal flakes 1 to include it in their normal diet.

Other: Dietary intervention

Dietary intervention: Participants receive dietary fibers for a defined number of days.

Experimental: Dietary fiber 2

Participants receive cereal flakes 2 to include it in their normal diet.

Other: Dietary intervention

Dietary intervention: Participants receive dietary fibers for a defined number of days.

Outcome Measures

Primary Outcome Measures

Changes in parameters of intestinal barrier function [1 week]
Changes in endotoxin plasma levels

Secondary Outcome Measures

Changes in blood lipid levels [1 week]
Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI <25 kg/m2
daily alcohol consumption <20g (men) or <10g (women)

Exclusion Criteria:

food allergies or intolerances
instable body weight
BMI <18,5 kg/m2 or >25 kg/m2
bariatric surgery within the last 5 years
intake of antibiotics within the last month or during the study
daily alcohol consumption >20g (men) or >10g (women)
pregnancy and/or lactation period
viral or bacterial infection during the last three weeks
increased inflammatory markers of unknown reason
chronic or acute disease of gastrointestinal tract

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Vienna	Vienna		Austria

Sponsors and Collaborators

University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Ina Bergheim, Principal Investigator, University of Vienna

ClinicalTrials.gov Identifier:

NCT04019457

Other Study ID Numbers:

UVienna19

First Posted:

Jul 15, 2019

Last Update Posted:

Nov 30, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endotoxemia

Study Results

No Results Posted as of Nov 30, 2020