ClinicalTrials.gg
CompletedNCT03482284ENDO-METAUpdated Apr 17, 2019

Effect of Monosaccharides on Intestinal Barrier Function

An interventional study of Dietary Intervention in Dietary Habits and Endotoxemia, sponsored by Prof. Dr. Ina Bergheim. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Prof. Dr. Ina Bergheim · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dietary Habits
  • Endotoxemia
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 12 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

This is the only study on the registry with Prof. Dr. Ina Bergheim as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 75 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
  • no kown history of metabolic disorders or fatty liver

Exclusion criteria

Exclusion Criteria:

  • food allergies or intolerances (esp. fructose intolerance and malabsorption)
  • renal insufficiency
  • chronic disease of the gastrointestinal tract
  • taking drugs affecting lipid or glucose metabolism
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
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Monosaccharide 1

    Participants receive standardized meals with a defined amount of monosaccharide 1.

    Other: Dietary Intervention

  • Experimental
    Monosaccharide 2

    Participants receive standardized meals with a defined amount of monosaccharide 2.

    Other: Dietary Intervention

Interventions

  • OtherDietary Intervention

    Participants receive different monosaccharides 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 pressure

    Changes in systolic and diastolic blood pressure

    Time frame: 1 week

  2. Changes in markers for glucose metabolism

    Changes in fasting glucose and fasting insulin levels

    Time frame: 1 week

  3. Changes in blood lipid levels

    Changes in triglyceride levels

    Time frame: 1 week

  4. Changes in Uric Acid levels

    Changes in Uric Acid blood levels

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03482284
Lead sponsor
Prof. Dr. Ina Bergheim
Responsible party
Prof. Dr. Ina Bergheim (Prof. Dr., University of Vienna) — Sponsor-investigator
First posted
Mar 29, 2018
Start date
May 20, 2016
Primary completion
Sep 9, 2017
Completion
Aug 1, 2018
Last update
Apr 17, 2019

Oversight

Data monitoring committee
No
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 Apr 2019. You cannot join it, but the record below documents what was studied.

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