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NCT03482284 Clinical Trial

Effect of Monosaccharides on Intestinal Barrier Function

Dietary Habits Clinical Trial

— ENDO-META  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03482284
Other study ID # UVienna18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2016
Est. completion date August 1, 2018

Study information
Verified date April 2019
Source University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 1, 2018
Est. primary completion date September 9, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Dietary Intervention
Participants receive different monosaccharides for a defined number of days.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Prof. Dr. Ina Bergheim

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in parameters of intestinal barrier function Changes in endotoxin plasma levels 1 week
Secondary Changes in blood pressure Changes in systolic and diastolic blood pressure 1 week
Secondary Changes in markers for glucose metabolism Changes in fasting glucose and fasting insulin levels 1 week
Secondary Changes in blood lipid levels Changes in triglyceride levels 1 week
Secondary Changes in Uric Acid levels Changes in Uric Acid blood levels 1 week
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