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

NCT ID: NCT04788680

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Dietary Habits Endotoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants receive all interventional diets
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Beverage 1

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

Group Type EXPERIMENTAL

Dietary intervention 1

Intervention Type OTHER

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

Experimental: Beverage 2

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

Group Type EXPERIMENTAL

Dietary Intervention 2

Intervention Type OTHER

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

Experimental: Beverage 3

Participants receive a beverage with a defined amount of monosaccharide.

Group Type EXPERIMENTAL

Dietary Intervention 3

Intervention Type OTHER

Participants receive a beverage with a defined amount of monosaccharide.

Experimental: Beverage 4

Participants receive a beverage with a defined amount of disaccharide.

Group Type EXPERIMENTAL

Dietary Intervention 4

Intervention Type OTHER

Participants receive a beverage with a defined amount of disaccharide.

Interventions

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Dietary intervention 1

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

Intervention Type OTHER

Dietary Intervention 2

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

Intervention Type OTHER

Dietary Intervention 3

Participants receive a beverage with a defined amount of monosaccharide.

Intervention Type OTHER

Dietary Intervention 4

Participants receive a beverage with a defined amount of disaccharide.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Ina Bergheim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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UVienna21

Identifier Type: -

Identifier Source: org_study_id

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