EndotoxemiaNCT04019457
Cereals and Intestinal Function
A study testing Dietary intervention in people with Endotoxemia and Diet, Healthy, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia, Diet, Healthy
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2018to 28 Feb 2020
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI <25 kg/m2
- daily alcohol consumption <20g (men) or <10g (women)
Who cannot join
- food allergies or intolerances
- instable body weight
- BMI <18,5 kg/m2 or >25 kg/m2
- bariatric surgery within the last 5 years
- intake of antibiotics within the last month or during the study
- daily alcohol consumption >20g (men) or >10g (women)
Show all 10Show fewer
- pregnancy and/or lactation period
- viral or bacterial infection during the last three weeks
- increased inflammatory markers of unknown reason
- chronic or acute disease of gastrointestinal tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cereals and Intestinal Function: Investigations in Healthy Participants
The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.
Read the detailed description
In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.
- Conditions
- Endotoxemia, Diet, Healthy
- Being tested
- Dietary intervention
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Dietary intervention: Participants receive dietary fibers for a defined number of days.
| Study group | Role | What they receive |
|---|---|---|
| Dietary fiber 1 | Experimental | Participants receive cereal flakes 1 to include it in their normal diet. Receives: Other: Dietary intervention |
| Dietary fiber 2 | Experimental | Participants receive cereal flakes 2 to include it in their normal diet. 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 (1)
Changes in blood lipid levels
Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)
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 posted15 Jul 2019
- Study start1 Aug 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndotoxemiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 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
- NCT04019457
- Sponsor's protocol ID
- UVienna19
- Status last verified
- Nov 2020
- First submitted
- 10 Jul 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cereals and Intestinal Function: Investigations in Healthy Participants
- ClinicalTrials.gov ID
- NCT04019457
- Acronym / sponsor ID
- UVienna19
- Conditions
- Endotoxemia, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 15 Jul 2019 (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 dietary fiber on intestinal function in healthy subjects.
Detailed description
In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary fiber 1 | Experimental | Other: Dietary interventionParticipants receive cereal flakes 1 to include it in their normal diet. |
| Dietary fiber 2 | Experimental | Other: Dietary interventionParticipants receive cereal flakes 2 to include it in their normal diet. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI <25 kg/m2
- daily alcohol consumption <20g (men) or <10g (women)
Key exclusion criteria (10 listed)
- food allergies or intolerances
- instable body weight
- BMI <18,5 kg/m2 or >25 kg/m2
- bariatric surgery within the last 5 years
- intake of antibiotics within the last month or during the study
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 interventionDietary intervention: Participants receive dietary fibers for a defined number of days. | Other | Dietary fiber 1, Dietary fiber 2 |
Primary outcome
Changes in parameters of intestinal barrier function
Time frame: 1 week
Changes in endotoxin plasma levels
1 secondary outcome
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 30 Nov 2020.
- 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 in people with Endotoxemia and Diet, Healthy, 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 10 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 30 Nov 2020. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2020.