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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482284
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ina Bergheim, University of Vienna

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : September 9, 2017
Actual Study Completion Date : August 1, 2018

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.




Primary Outcome Measures :
  1. Changes in parameters of intestinal barrier function [ Time Frame: 1 week ]
    Changes in endotoxin plasma levels


Secondary Outcome Measures :
  1. Changes in blood pressure [ Time Frame: 1 week ]
    Changes in systolic and diastolic blood pressure

  2. Changes in markers for glucose metabolism [ Time Frame: 1 week ]
    Changes in fasting glucose and fasting insulin levels

  3. Changes in blood lipid levels [ Time Frame: 1 week ]
    Changes in triglyceride levels

  4. Changes in Uric Acid levels [ Time Frame: 1 week ]
    Changes in Uric Acid blood levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Prof. Dr. Ina Bergheim, Prof. Dr., University of Vienna
ClinicalTrials.gov Identifier: NCT03482284    
Other Study ID Numbers: UVienna18
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes