Effect of Monosaccharides on Intestinal Barrier Function (ENDO-META)

April 16, 2019 updated by: Prof. Dr. Ina Bergheim

Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood pressure
Time Frame: 1 week
Changes in systolic and diastolic blood pressure
1 week
Changes in markers for glucose metabolism
Time Frame: 1 week
Changes in fasting glucose and fasting insulin levels
1 week
Changes in blood lipid levels
Time Frame: 1 week
Changes in triglyceride levels
1 week
Changes in Uric Acid levels
Time Frame: 1 week
Changes in Uric Acid blood levels
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Ina Bergheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2016

Primary Completion (Actual)

September 9, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVienna18

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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