Cereals and Intestinal Function

NCT ID: NCT04019457

Last Updated: 2020-11-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endotoxemia Diet, Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary fiber 1

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

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

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

Dietary fiber 2

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

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary intervention

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Ina Bergheim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UVienna19

Identifier Type: -

Identifier Source: org_study_id