Dietary HabitsENDO-METANCT03482284
Effect of Monosaccharides on Intestinal Barrier Function
A study testing Dietary Intervention in people with Dietary Habits and Endotoxemia, run by Prof. Dr. Ina Bergheim.
Trial summary
The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Endotoxemia
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2016to 1 Aug 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI <25 kg/m2
- no kown history of metabolic disorders or fatty liver
Who cannot join
- food allergies or intolerances (esp. fructose intolerance and malabsorption)
- renal insufficiency
- chronic disease of the gastrointestinal tract
- taking drugs affecting lipid or glucose metabolism
About this study
Official title: Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients
The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects.
Read the detailed description
In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.
- Conditions
- Dietary Habits, Endotoxemia
- Being tested
- Dietary Intervention
- 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 InterventionOther
Participants receive different monosaccharides for a defined number of days.
| Study group | Role | What they receive |
|---|---|---|
| Monosaccharide 1 | Experimental | Participants receive standardized meals with a defined amount of monosaccharide 1. Receives: Other: Dietary Intervention |
| Monosaccharide 2 | Experimental | Participants receive standardized meals with a defined amount of monosaccharide 2. Receives: Other: Dietary Intervention |
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 endotoxin plasma levels
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 and fasting insulin levels
Measured: 1 week
Changes in blood lipid levels
Changes in triglyceride levels
Measured: 1 week
Changes in Uric Acid levels
Changes in Uric Acid blood 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 posted29 Mar 2018
- Study start20 May 2016
- Primary completion9 Sep 2017
- Study completion1 Aug 2018
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
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants receive all interventional diets.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Ina Bergheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Ina Bergheim, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482284
- Sponsor's protocol ID
- UVienna18
- Acronym
- ENDO-META
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients
- ClinicalTrials.gov ID
- NCT03482284
- Acronym / sponsor ID
- ENDO-META / UVienna18
- Conditions
- Dietary Habits, Endotoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prof. Dr. Ina BergheimUniversity, hospital or other
- Study start
- 20 May 2016 (actual)
- Primary completion
- 9 Sep 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 29 Mar 2018 (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 monosaccharides on intestinal barrier function in healthy subjects.
Detailed description
In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive all interventional diets.
| Arm | Type | Receives |
|---|---|---|
| Monosaccharide 1 | Experimental | Other: Dietary InterventionParticipants receive standardized meals with a defined amount of monosaccharide 1. |
| Monosaccharide 2 | Experimental | Other: Dietary InterventionParticipants receive standardized meals with a defined amount of monosaccharide 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI <25 kg/m2
- no kown history of metabolic disorders or fatty liver
Key exclusion criteria (4 listed)
- food allergies or intolerances (esp. fructose intolerance and malabsorption)
- renal insufficiency
- chronic disease of the gastrointestinal tract
- 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 InterventionParticipants receive different monosaccharides for a defined number of days. | Other | Monosaccharide 1, Monosaccharide 2 |
Primary outcome
Changes in parameters of intestinal barrier function
Time frame: 1 week
Changes in endotoxin plasma levels
4 secondary outcomes
Changes in blood pressure
Time frame: 1 week
Changes in markers for glucose metabolism
Time frame: 1 week
Changes in blood lipid levels
Time frame: 1 week
Changes in Uric Acid 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 17 Apr 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Dietary Habits and Endotoxemia, run by Prof. Dr. Ina Bergheim.
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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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). 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 NCT03482284, 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 17 Apr 2019.