Cereals and Intestinal Function

Cereals and Intestinal Function: Investigations in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: Endotoxemia; Diet, Healthy
• Intervention / Treatment: Other: Dietary intervention

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary fiber 1; Participants receive cereal flakes 1 to include it in their normal diet.	Other: Dietary intervention; Dietary intervention: Participants receive dietary fibers for a defined number of days.
Experimental: Dietary fiber 2; Participants receive cereal flakes 2 to include it in their normal diet.	Other: Dietary intervention; Dietary intervention: Participants receive dietary fibers for a defined number of days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parameters of intestinal barrier function	Changes in endotoxin plasma levels	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood lipid levels	Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)	1 week

Collaborators and Investigators

• Sponsor: University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Bacteremia; Toxemia; Endotoxemia
• Other Study ID Numbers: UVienna19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No