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OpenTrials
Completed

NCT Number: NCT03482284

Effect of Monosaccharides on Intestinal Barrier Function

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

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Key information

Conditions

Dietary Habits Bacteremia Behavior Behavior, Animal Endotoxemia Feeding Behavior Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

Participants receive different monosaccharides for a defined number of days.

Primary outcomes

  1. Changes in parameters of intestinal barrier function

    Time frame: 1 week

    Changes in endotoxin plasma levels

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Ina Bergheim

Other

Registry information

Official study title

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

Acronym: ENDO-META

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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