Dietary HabitsNCT04788680
Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
A study testing Dietary intervention 1, Dietary Intervention 2 and Dietary Intervention 3 in people with Dietary Habits and Endotoxemia, run by University of Vienna at 1 site in Austria.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Endotoxemia
- What is being tested?
- Dietary intervention 1, Dietary Intervention 2 and Dietary Intervention 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No known history of metabolic diseases/disorders
- BMI <25 kg/m2
Who cannot join
- Food allergies or intolerances (esp. fructose intolerance and malabsorption)
- Chronic disease of the gastrointestinal tract
- Renal insufficiency
- Taking drugs affecting lipid or glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Dietary Habits, Endotoxemia
- Being tested
- Dietary intervention 1, Dietary Intervention 2, Dietary Intervention 3, Dietary Intervention 4
- Medical subject headings
- Feeding Behavior, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention 1Other
Participants receive a beverage with a defined amount of non-nutritive sweetener.
Dietary Intervention 2Other
Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
Dietary Intervention 3Other
Participants receive a beverage with a defined amount of monosaccharide.
Dietary Intervention 4Other
Participants receive a beverage with a defined amount of disaccharide.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Beverage 1 | Experimental | Participants receive a beverage with a defined amount of non-nutritive sweetener. Receives: Other: Dietary intervention 1 |
| Experimental: Beverage 2 | Experimental | Participants receive a beverage with a defined amount of non-nutritive sweetener. Receives: Other: Dietary Intervention 2 |
| Experimental: Beverage 3 | Experimental | Participants receive a beverage with a defined amount of monosaccharide. Receives: Other: Dietary Intervention 3 |
| Experimental: Beverage 4 | Experimental | Participants receive a beverage with a defined amount of disaccharide. Receives: Other: Dietary Intervention 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parameters of intestinal barrier function.
Changes in plasma endotoxin levels.
Measured: 1 week
Changes in inflammatory markers.
Changes in IL-6 plasma levels (ng/ml).
Measured: 1 week
Secondary outcomes (4)
Changes in blood pressure.
Changes in systolic and diastolic blood pressure
Measured: 1 week
Changes in markers for glucose metabolism.
Changes in fasting glucose (mg/dl) and fasting insulin levels (mU/l)
Measured: 1 week
Changes in markers for glucose metabolism.
Changes in fasting insulin levels (mU/l).
Measured: 1 week
Changes in blood lipid levels.
Changes in triglyceride levels.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive all interventional diets
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ina Bergheim, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788680
- Sponsor's protocol ID
- UVienna21
- Status last verified
- Oct 2023
- First submitted
- 25 Feb 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staltner R, Csarmann K, Geyer A, Nier A, Baumann A, Bergheim I. Fructose intake enhances lipoteichoic acid-mediated immune response in monocytes of healthy humans. Redox Biol. 2025 Sep;85:103729. doi: 10.1016/j.redox.2025.103729. Epub 2025 Jun 12.
PubMed 40517600
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04788680
- Acronym / sponsor ID
- UVienna21
- Conditions
- Dietary Habits, Endotoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- All participants receive all interventional diets
| Arm | Type | Receives |
|---|---|---|
| Experimental: Beverage 1 | Experimental | Other: Dietary intervention 1Participants receive a beverage with a defined amount of non-nutritive sweetener. |
| Experimental: Beverage 2 | Experimental | Other: Dietary Intervention 2Participants receive a beverage with a defined amount of non-nutritive sweetener. |
| Experimental: Beverage 3 | Experimental | Other: Dietary Intervention 3Participants receive a beverage with a defined amount of monosaccharide. |
| Experimental: Beverage 4 | Experimental | Other: Dietary Intervention 4Participants receive a beverage with a defined amount of disaccharide. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No known history of metabolic diseases/disorders
- BMI <25 kg/m2
Key exclusion criteria (4 listed)
- Food allergies or intolerances (esp. fructose intolerance and malabsorption)
- Chronic disease of the gastrointestinal tract
- Renal insufficiency
- Taking drugs affecting lipid or glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention 1Participants receive a beverage with a defined amount of non-nutritive sweetener. | Other | Experimental: Beverage 1 |
| Dietary Intervention 2Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin. | Other | Experimental: Beverage 2 |
| Dietary Intervention 3Participants receive a beverage with a defined amount of monosaccharide. | Other | Experimental: Beverage 3 |
| Dietary Intervention 4Participants receive a beverage with a defined amount of disaccharide. | Other | Experimental: Beverage 4 |
Primary outcome
Changes in parameters of intestinal barrier function.
Time frame: 1 week
Changes in plasma endotoxin levels.
Changes in inflammatory markers.
Time frame: 1 week
Changes in IL-6 plasma levels (ng/ml).
4 secondary outcomes
Changes in blood pressure.
Time frame: 1 week
Changes in markers for glucose metabolism.
Time frame: 1 week
Changes in markers for glucose metabolism.
Time frame: 1 week
Changes in blood lipid levels.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 40517600Staltner R, Csarmann K, Geyer A, Nier A, Baumann A, Bergheim I. Fructose intake enhances lipoteichoic acid-mediated immune response in monocytes of healthy humans. Redox Biol. 2025 Sep;85:103729. doi: 10.1016/j.redox.2025.103729. Epub 2025 Jun 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention 1, Dietary Intervention 2 and Dietary Intervention 3 in people with Dietary Habits and Endotoxemia, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parameters of intestinal barrier function. (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.