Back to resultsEffect of Monosaccharides on Intestinal Barrier Function (ENDO-META)
Primary Purpose
Dietary Habits, Endotoxemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional basic science trial for Dietary Habits
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Monosaccharide 1
Monosaccharide 2
Arm Description
Participants receive standardized meals with a defined amount of monosaccharide 1.
Participants receive standardized meals with a defined amount of monosaccharide 2.
Outcomes
Primary Outcome Measures
Changes in parameters of intestinal barrier function
Changes in endotoxin plasma levels
Secondary Outcome Measures
Changes in blood pressure
Changes in systolic and diastolic blood pressure
Changes in markers for glucose metabolism
Changes in fasting glucose and fasting insulin levels
Changes in blood lipid levels
Changes in triglyceride levels
Changes in Uric Acid levels
Changes in Uric Acid blood levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03482284
Brief Title
Effect of Monosaccharides on Intestinal Barrier Function
Acronym
ENDO-META
Official Title
Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 20, 2016 (Actual)
Primary Completion Date
September 9, 2017 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Ina Bergheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Endotoxemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants receive all interventional diets.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monosaccharide 1
Arm Type
Experimental
Arm Description
Participants receive standardized meals with a defined amount of monosaccharide 1.
Arm Title
Monosaccharide 2
Arm Type
Experimental
Arm Description
Participants receive standardized meals with a defined amount of monosaccharide 2.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Participants receive different monosaccharides for a defined number of days.
Primary Outcome Measure Information:
Title
Changes in parameters of intestinal barrier function
Description
Changes in endotoxin plasma levels
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Changes in blood pressure
Description
Changes in systolic and diastolic blood pressure
Time Frame
1 week
Title
Changes in markers for glucose metabolism
Description
Changes in fasting glucose and fasting insulin levels
Time Frame
1 week
Title
Changes in blood lipid levels
Description
Changes in triglyceride levels
Time Frame
1 week
Title
Changes in Uric Acid levels
Description
Changes in Uric Acid blood levels
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Monosaccharides on Intestinal Barrier Function
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