ENDO-META: Effect of Monosaccharides on Intestinal Barrier Function

• Sponsor: Prof. Dr. Ina Bergheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT03482284
• Collaborator: (none)
• Enrollment: 12
• Arms: 2
• Actual Duration (Months): 26.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dietary Habits; Endotoxemia	Other: Dietary Intervention	N/A

Detailed Description

In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All participants receive all interventional diets.All participants receive all interventional diets.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients
• Actual Study Start Date: May 20, 2016
• Actual Primary Completion Date: Sep 9, 2017
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monosaccharide 1 Participants receive standardized meals with a defined amount of monosaccharide 1.	Other: Dietary Intervention; Participants receive different monosaccharides for a defined number of days.
Experimental: Monosaccharide 2 Participants receive standardized meals with a defined amount of monosaccharide 2.	Other: Dietary Intervention; Participants receive different monosaccharides for a defined number of days.

Outcome Measures

Primary Outcome Measures

1. Changes in parameters of intestinal barrier function [1 week]

   Changes in endotoxin plasma levels

Secondary Outcome Measures

1. Changes in blood pressure [1 week]

   Changes in systolic and diastolic blood pressure

2. Changes in markers for glucose metabolism [1 week]

   Changes in fasting glucose and fasting insulin levels

3. Changes in blood lipid levels [1 week]

   Changes in triglyceride levels

4. Changes in Uric Acid levels [1 week]

   Changes in Uric Acid blood levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI <25 kg/m2

• no kown history of metabolic disorders or fatty liver

Exclusion Criteria:

• food allergies or intolerances (esp. fructose intolerance and malabsorption)

• renal insufficiency

• chronic disease of the gastrointestinal tract

• taking drugs affecting lipid or glucose metabolism

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Prof. Dr. Ina Bergheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Ina Bergheim, Prof. Dr., University of Vienna
• ClinicalTrials.gov Identifier: NCT03482284
• Other Study ID Numbers: UVienna18
• First Posted: Mar 29, 2018
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endotoxemia

Study Results

No Results Posted as of Apr 17, 2019