NCT03482284

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

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

May 20, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

March 20, 2018

Last Update Submit

April 16, 2019

Conditions

Dietary HabitsEndotoxemia

Outcome Measures

Primary Outcomes (1)

  • Changes in parameters of intestinal barrier function

    Changes in endotoxin plasma levels

    1 week

Secondary Outcomes (4)

  • Changes in blood pressure

    1 week

  • Changes in markers for glucose metabolism

    1 week

  • Changes in blood lipid levels

    1 week

  • Changes in Uric Acid levels

    1 week

Study Arms (2)

Monosaccharide 1

EXPERIMENTAL

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

Other: Dietary Intervention

Monosaccharide 2

EXPERIMENTAL

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

Other: Dietary Intervention

Interventions

Dietary InterventionOTHER

Participants receive different monosaccharides for a defined number of days.

Monosaccharide 1Monosaccharide 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \<25 kg/m2
  • no kown history of metabolic disorders or fatty liver

You may not qualify if:

  • food allergies or intolerances (esp. fructose intolerance and malabsorption)
  • renal insufficiency
  • chronic disease of the gastrointestinal tract
  • taking drugs affecting lipid or glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding BehaviorEndotoxemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: All participants receive all interventional diets.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 29, 2018

Study Start

May 20, 2016

Primary Completion

September 9, 2017

Study Completion

August 1, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share