Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
Primary Purpose
Dietary Habits, Endotoxemia
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dietary intervention 1
Dietary Intervention 2
Dietary Intervention 3
Dietary Intervention 4
Sponsored by
About this trial
This is an interventional basic science trial for Dietary Habits
Eligibility Criteria
Inclusion Criteria:
- No known history of metabolic diseases/disorders
- BMI <25 kg/m2
Exclusion Criteria:
- Food allergies or intolerances (esp. fructose intolerance and malabsorption)
- Chronic disease of the gastrointestinal tract
- Renal insufficiency
- Taking drugs affecting lipid or glucose metabolism
Sites / Locations
- University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Experimental: Beverage 1
Experimental: Beverage 2
Experimental: Beverage 3
Experimental: Beverage 4
Arm Description
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Participants receive a beverage with a defined amount of monosaccharide.
Participants receive a beverage with a defined amount of disaccharide.
Outcomes
Primary Outcome Measures
Changes in parameters of intestinal barrier function.
Changes in plasma endotoxin levels.
Changes in inflammatory markers.
Changes in IL-6 plasma levels (ng/ml).
Secondary Outcome Measures
Changes in blood pressure.
Changes in systolic and diastolic blood pressure
Changes in markers for glucose metabolism.
Changes in fasting glucose (mg/dl) and fasting insulin levels (mU/l)
Changes in markers for glucose metabolism.
Changes in fasting insulin levels (mU/l).
Changes in blood lipid levels.
Changes in triglyceride levels.
Full Information
NCT ID
NCT04788680
First Posted
February 25, 2021
Last Updated
November 2, 2022
Sponsor
University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04788680
Brief Title
Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
Official Title
Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.
Detailed Description
In the intervention study normal weight participants will receive beverages sweetened with non-nutritive sweeteners, mono- and disaccharides for a defined number of 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
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Beverage 1
Arm Type
Experimental
Arm Description
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Arm Title
Experimental: Beverage 2
Arm Type
Experimental
Arm Description
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Arm Title
Experimental: Beverage 3
Arm Type
Experimental
Arm Description
Participants receive a beverage with a defined amount of monosaccharide.
Arm Title
Experimental: Beverage 4
Arm Type
Experimental
Arm Description
Participants receive a beverage with a defined amount of disaccharide.
Intervention Type
Other
Intervention Name(s)
Dietary intervention 1
Intervention Description
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention 2
Intervention Description
Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention 3
Intervention Description
Participants receive a beverage with a defined amount of monosaccharide.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention 4
Intervention Description
Participants receive a beverage with a defined amount of disaccharide.
Primary Outcome Measure Information:
Title
Changes in parameters of intestinal barrier function.
Description
Changes in plasma endotoxin levels.
Time Frame
1 week
Title
Changes in inflammatory markers.
Description
Changes in IL-6 plasma levels (ng/ml).
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 (mg/dl) and fasting insulin levels (mU/l)
Time Frame
1 week
Title
Changes in markers for glucose metabolism.
Description
Changes in fasting insulin levels (mU/l).
Time Frame
1 week
Title
Changes in blood lipid levels.
Description
Changes in triglyceride levels.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No known history of metabolic diseases/disorders
BMI <25 kg/m2
Exclusion Criteria:
Food allergies or intolerances (esp. fructose intolerance and malabsorption)
Chronic disease of the gastrointestinal tract
Renal insufficiency
Taking drugs affecting lipid or glucose metabolism
Facility Information:
Facility Name
University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ina Bergheim, Prof. Dr.
Phone
+43 1 4277 54981
Email
ina.bergheim@univie.ac.at
First Name & Middle Initial & Last Name & Degree
Anja Baumann, Dr.
Phone
+43 1 4277 54985
Email
anja.baumann@univie.ac.at
First Name & Middle Initial & Last Name & Degree
Raphaela Staltner, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
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