Cereals and Intestinal Function

Not Applicable

Completed

• Conditions: Diet, Healthy; Endotoxemia
• Interventions: Other: Dietary intervention

• Registration Number: NCT04019457
• Lead Sponsor: University of Vienna

Brief Summary

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

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 Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-15
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dietary fiber 1	Dietary intervention	Participants receive cereal flakes 1 to include it in their normal diet.
Dietary fiber 2	Dietary intervention	Participants receive cereal flakes 2 to include it in their normal diet.

Primary Outcome Measures

Name	Time	Method
Changes in parameters of intestinal barrier function	1 week	Changes in endotoxin plasma levels

Secondary Outcome Measures

Name	Time	Method
Changes in blood lipid levels	1 week	Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria