Back to resultsCereals and Intestinal Function
Primary Purpose
Endotoxemia, Diet, Healthy
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Endotoxemia
Eligibility Criteria
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
Sites / Locations
- University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dietary fiber 1
Dietary fiber 2
Arm Description
Participants receive cereal flakes 1 to include it in their normal diet.
Participants receive cereal flakes 2 to include it in their normal diet.
Outcomes
Primary Outcome Measures
Changes in parameters of intestinal barrier function
Changes in endotoxin plasma levels
Secondary Outcome Measures
Changes in blood lipid levels
Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019457
Brief Title
Cereals and Intestinal Function
Official Title
Cereals and Intestinal Function: Investigations in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia, Diet, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary fiber 1
Arm Type
Experimental
Arm Description
Participants receive cereal flakes 1 to include it in their normal diet.
Arm Title
Dietary fiber 2
Arm Type
Experimental
Arm Description
Participants receive cereal flakes 2 to include it in their normal diet.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Dietary intervention: Participants receive dietary fibers for a defined number of days.
Primary Outcome Measure Information:
Title
Changes in parameters of intestinal barrier function
Description
Changes in endotoxin plasma levels
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Changes in blood lipid levels
Description
Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Cereals and Intestinal Function
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