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OpenTrials
Completed

NCT Number: NCT04788680

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

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.

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Key information

Conditions

Dietary Habits Bacteremia Behavior Behavior, Animal Endotoxemia Feeding Behavior Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention 1

Other

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

Dietary Intervention 2

Other

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

Dietary Intervention 3

Other

Participants receive a beverage with a defined amount of monosaccharide.

Dietary Intervention 4

Other

Participants receive a beverage with a defined amount of disaccharide.

Primary outcomes

  1. Changes in parameters of intestinal barrier function.

    Time frame: 1 week

    Changes in plasma endotoxin levels.

  2. Changes in inflammatory markers.

    Time frame: 1 week

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

Secondary outcomes

  1. Changes in blood pressure.

    Time frame: 1 week

    Changes in systolic and diastolic blood pressure

  2. Changes in markers for glucose metabolism.

    Time frame: 1 week

    Changes in fasting glucose (mg/dl) and fasting insulin levels (mU/l)

  3. Changes in markers for glucose metabolism.

    Time frame: 1 week

    Changes in fasting insulin levels (mU/l).

  4. Changes in blood lipid levels.

    Time frame: 1 week

    Changes in triglyceride levels.

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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