Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function

Dietary Habits Clinical Trial

Official title:

Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788680
• Other study ID #: UVienna21
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits
• Endotoxemia

Intervention

Other:
• Dietary intervention 1
Participants receive a beverage with a defined amount of non-nutritive sweetener.
• Dietary Intervention 2
Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
• Dietary Intervention 3
Participants receive a beverage with a defined amount of monosaccharide.
• Dietary Intervention 4
Participants receive a beverage with a defined amount of disaccharide.

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in parameters of intestinal barrier function.	Changes in plasma endotoxin levels.	1 week
Primary	Changes in inflammatory markers.	Changes in IL-6 plasma levels (ng/ml).	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 (mg/dl) and fasting insulin levels (mU/l)	1 week
Secondary	Changes in markers for glucose metabolism.	Changes in fasting insulin levels (mU/l).	1 week
Secondary	Changes in blood lipid levels.	Changes in triglyceride levels.	1 week