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Completed

NCT Number: NCT04019457

Cereals and Intestinal Function

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

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Key information

Conditions

Endotoxemia Bacteremia Diet, Healthy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. Changes in parameters of intestinal barrier function

    Time frame: 1 week

    Changes in endotoxin plasma levels

Secondary outcomes

  1. Changes in blood lipid levels

    Time frame: 1 week

    Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Cereals and Intestinal Function: Investigations in Healthy Participants

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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