Gut Permeability and Stress (SP15)

September 6, 2017 updated by: Caroline Linninge, Lund University

Gut Permeability in Volunteers Participating in a Stress Test

The purpose of this study is to analyse gut permeability and stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.

Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 00
        • Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Healthy men aged 19-35 years old

Description

Inclusion Criteria:

  • Man, 19-35 years old
  • Healthy

Exclusion Criteria:

  • Psychological disorders
  • Use of antibiotics or other drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stressed
stressed volunteers perform Trier social stress test
Other: Trier social stress test
Volunteers perform Trier social stress test
non-stressed
non-stressed volunteers perform Trier social stress test
Other: Trier social stress test
Volunteers perform Trier social stress test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test
Time Frame: Volunteers will be followed by one hour after Trier social stress test
Volunteers will be followed by one hour after Trier social stress test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Caroline Linninge, PhD, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • SP15_CarolineLinninge

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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