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Clinical Trials/NCT04788680
NCT04788680CompletedNot Applicable

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

University of Vienna1 site in 1 country18 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Changes in inflammatory markers.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Experimental: Beverage 1

Experimental

Participants receive a beverage with a defined amount of non-nutritive sweetener.

Intervention: Dietary intervention 1 (Other)

Experimental: Beverage 2

Experimental

Participants receive a beverage with a defined amount of non-nutritive sweetener.

Intervention: Dietary Intervention 2 (Other)

Experimental: Beverage 3

Experimental

Participants receive a beverage with a defined amount of monosaccharide.

Intervention: Dietary Intervention 3 (Other)

Experimental: Beverage 4

Experimental

Participants receive a beverage with a defined amount of disaccharide.

Intervention: Dietary Intervention 4 (Other)

Outcomes

Primary Outcomes

Changes in inflammatory markers.

Time Frame: 1 week

Changes in IL-6 plasma levels (ng/ml).

Changes in parameters of intestinal barrier function.

Time Frame: 1 week

Changes in plasma endotoxin levels.

Secondary Outcomes

  • Changes in markers for glucose metabolism.(1 week)
  • Changes in blood lipid levels.(1 week)
  • Changes in blood pressure.(1 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Ina Bergheim

Principal Investigator

University of Vienna

Study Sites (1)

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