CClinicalTrials.gg
CompletedNCT04788680Updated Nov 1, 2023

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

An interventional study of Dietary intervention 1 and Dietary Intervention 2 in Dietary Habits and Endotoxemia, sponsored by University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by University of Vienna · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dietary Habits
  • Endotoxemia

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No known history of metabolic diseases/disorders
  • BMI \<25 kg/m2

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Experimental: Beverage 1

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

    Other: Dietary intervention 1

  • Experimental
    Experimental: Beverage 2

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

    Other: Dietary Intervention 2

  • Experimental
    Experimental: Beverage 3

    Participants receive a beverage with a defined amount of monosaccharide.

    Other: Dietary Intervention 3

  • Experimental
    Experimental: Beverage 4

    Participants receive a beverage with a defined amount of disaccharide.

    Other: Dietary Intervention 4

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.

05

What researchers measure

Primary outcomes

  1. Changes in parameters of intestinal barrier function.

    Changes in plasma endotoxin levels.

    Time frame: 1 week

  2. Changes in inflammatory markers.

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

    Time frame: 1 week

Secondary outcomes

  1. Changes in blood pressure.

    Changes in systolic and diastolic blood pressure

    Time frame: 1 week

  2. Changes in markers for glucose metabolism.

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

    Time frame: 1 week

  3. Changes in markers for glucose metabolism.

    Changes in fasting insulin levels (mU/l).

    Time frame: 1 week

  4. Changes in blood lipid levels.

    Changes in triglyceride levels.

    Time frame: 1 week

06

Study locations

1 site
  • University of Vienna
    Vienna, 1090, Austria
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04788680
Lead sponsor
University of Vienna
Responsible party
Prof. Dr. Ina Bergheim (Principal Investigator, University of Vienna) — Principal investigator
First posted
Mar 9, 2021
Start date
Mar 1, 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Nov 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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