Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 1, 2023
October 1, 2023
1.8 years
February 25, 2021
October 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in parameters of intestinal barrier function.
Changes in plasma endotoxin levels.
1 week
Changes in inflammatory markers.
Changes in IL-6 plasma levels (ng/ml).
1 week
Secondary Outcomes (4)
Changes in blood pressure.
1 week
Changes in markers for glucose metabolism.
1 week
Changes in markers for glucose metabolism.
1 week
Changes in blood lipid levels.
1 week
Study Arms (4)
Experimental: Beverage 1
EXPERIMENTALParticipants receive a beverage with a defined amount of non-nutritive sweetener.
Experimental: Beverage 2
EXPERIMENTALParticipants receive a beverage with a defined amount of non-nutritive sweetener.
Experimental: Beverage 3
EXPERIMENTALParticipants receive a beverage with a defined amount of monosaccharide.
Experimental: Beverage 4
EXPERIMENTALParticipants receive a beverage with a defined amount of disaccharide.
Interventions
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
Participants receive a beverage with a defined amount of monosaccharide.
Participants receive a beverage with a defined amount of disaccharide.
Eligibility Criteria
You may qualify if:
- No known history of metabolic diseases/disorders
- BMI \<25 kg/m2
You may not qualify if:
- Food allergies or intolerances (esp. fructose intolerance and malabsorption)
- Chronic disease of the gastrointestinal tract
- Renal insufficiency
- Taking drugs affecting lipid or glucose metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 9, 2021
Study Start
March 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
November 1, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share