NCT04019457CompletedNot Applicable
Cereals and Intestinal Function: Investigations in Healthy Participants
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Vienna
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Changes in parameters of intestinal barrier function
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
Dietary fiber 1
Experimental
Participants receive cereal flakes 1 to include it in their normal diet.
Intervention: Dietary intervention (Other)
Dietary fiber 2
Experimental
Participants receive cereal flakes 2 to include it in their normal diet.
Intervention: Dietary intervention (Other)
Outcomes
Primary Outcomes
Changes in parameters of intestinal barrier function
Time Frame: 1 week
Changes in endotoxin plasma levels
Secondary Outcomes
- Changes in blood lipid levels(1 week)
Investigators
Prof. Dr. Ina Bergheim
Principal Investigator
University of Vienna
Study Sites (1)
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