NCT04019457

Brief Summary

The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

July 10, 2019

Last Update Submit

November 27, 2020

Conditions

EndotoxemiaDiet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Changes in parameters of intestinal barrier function

    Changes in endotoxin plasma levels

    1 week

Secondary Outcomes (1)

  • Changes in blood lipid levels

    1 week

Study Arms (2)

Dietary fiber 1

EXPERIMENTAL

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

Other: Dietary intervention

Dietary fiber 2

EXPERIMENTAL

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

Other: Dietary intervention

Interventions

Dietary interventionOTHER

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

Dietary fiber 1Dietary fiber 2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Endotoxemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

BacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

August 1, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)