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

Not Applicable

Completed

• Conditions: Dietary Habits; Endotoxemia
• Interventions: Other: Dietary Intervention 2; Other: Dietary Intervention 4; Other: Dietary intervention 1; Other: Dietary Intervention 3

• Registration Number: NCT04788680
• Lead Sponsor: University of Vienna

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study Start: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Beverage 2	Dietary Intervention 2	Participants receive a beverage with a defined amount of non-nutritive sweetener.
Experimental: Beverage 4	Dietary Intervention 4	Participants receive a beverage with a defined amount of disaccharide.
Experimental: Beverage 1	Dietary intervention 1	Participants receive a beverage with a defined amount of non-nutritive sweetener.
Experimental: Beverage 3	Dietary Intervention 3	Participants receive a beverage with a defined amount of monosaccharide.

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory markers.	1 week	Changes in IL-6 plasma levels (ng/ml).
Changes in parameters of intestinal barrier function.	1 week	Changes in plasma endotoxin levels.

Secondary Outcome Measures

Name	Time	Method
Changes in markers for glucose metabolism.	1 week	Changes in fasting insulin levels (mU/l).
Changes in blood lipid levels.	1 week	Changes in triglyceride levels.
Changes in blood pressure.	1 week	Changes in systolic and diastolic blood pressure

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria