ClinicalTrials.gg
CompletedNCT04019457Updated Nov 30, 2020

Cereals and Intestinal Function

An interventional study of Dietary intervention in Endotoxemia and Diet, Healthy, sponsored by University of Vienna. Completed at 1 site in Austria. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by University of Vienna · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Endotoxemia
  • Diet, Healthy

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03

In context

Endotoxemia

81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.

This study's enrollment of 17 is below the median of 31 across 70 interventional studies indexed under Endotoxemia.

Browse Endotoxemia studies →

Lead sponsor

University of Vienna is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • \<25 kg/m2
  • daily alcohol consumption \<20g (men) or \<10g (women)

Exclusion criteria

Exclusion Criteria:

  • food allergies or intolerances
  • instable body weight
  • \<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)
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Dietary fiber 1

    Participants receive cereal flakes 1 to include it in their normal diet.

    Other: Dietary intervention

  • Experimental
    Dietary fiber 2

    Participants receive cereal flakes 2 to include it in their normal diet.

    Other: Dietary intervention

Interventions

  • OtherDietary intervention

    Dietary intervention: Participants receive dietary fibers for a defined number of days.

06

What researchers measure

Primary outcomes

  1. Changes in parameters of intestinal barrier function

    Changes in endotoxin plasma levels

    Time frame: 1 week

Secondary outcomes

  1. Changes in blood lipid levels

    Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)

    Time frame: 1 week

07

Study locations

1 site
  • University of Vienna
    Vienna, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Feb 2020, 18 months.

Of 29 non-industry interventional studies with no phase under Endotoxemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 18 months is close to that.

Counting every sponsor, half of 31 studies reached it within 17 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2019
First posted
Jul 15, 2019
StartActual
Aug 1, 2018
Primary completionActual
Feb 28, 2020
CompletionActual
Feb 28, 2020
Last update
Nov 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04019457
Lead sponsor
University of Vienna
Responsible party
Prof. Dr. Ina Bergheim (Principal Investigator, University of Vienna) — Principal investigator
First posted
Jul 15, 2019
Start date
Aug 1, 2018
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
Nov 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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