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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04788680

Enrollment

Registered

2021-03-09

Start date

2021-03-01

Completion date

2022-12-31

Last updated

2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits, Endotoxemia

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.

Interventions

OTHERDietary intervention 1

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

OTHERDietary Intervention 2

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

OTHERDietary Intervention 3

Participants receive a beverage with a defined amount of monosaccharide.

OTHERDietary Intervention 4

Participants receive a beverage with a defined amount of disaccharide.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Intervention model description

All participants receive all interventional diets

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Changes in blood pressure.	1 week	Changes in systolic and diastolic blood pressure
Changes in markers for glucose metabolism.	1 week	Changes in fasting glucose (mg/dl) and fasting insulin levels (mU/l)
Changes in blood lipid levels.	1 week	Changes in triglyceride levels.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026