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

October 31, 2023 updated by: Prof. Dr. Ina Bergheim, University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Beverage 1
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Other: Dietary intervention 1
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Experimental: Experimental: Beverage 2
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Other: Dietary Intervention 2
Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
Experimental: Experimental: Beverage 3
Participants receive a beverage with a defined amount of monosaccharide.
Other: Dietary Intervention 3
Participants receive a beverage with a defined amount of monosaccharide.
Experimental: Experimental: Beverage 4
Participants receive a beverage with a defined amount of disaccharide.
Other: Dietary Intervention 4
Participants receive a beverage with a defined amount of disaccharide.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVienna21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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