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

Sponsor

University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04788680

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Habits Endotoxemia	Other: Dietary intervention 1 Other: Dietary Intervention 2 Other: Dietary Intervention 3 Other: Dietary Intervention 4	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

All participants receive all interventional dietsAll participants receive all interventional diets

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 markers for glucose metabolism. [1 week]
Changes in fasting insulin levels (mU/l).
Changes in blood lipid levels. [1 week]
Changes in triglyceride levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Ina Bergheim, Principal Investigator, University of Vienna

ClinicalTrials.gov Identifier:

NCT04788680

Other Study ID Numbers:

UVienna21

First Posted:

Mar 9, 2021

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endotoxemia

Study Results

No Results Posted as of Mar 9, 2021