NCT02485405

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

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

June 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

June 23, 2015

Last Update Submit

September 6, 2017

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test

    Volunteers will be followed by one hour after Trier social stress test

Study Arms (2)

stressed

stressed volunteers perform Trier social stress test

Other: Trier social stress test

non-stressed

non-stressed volunteers perform Trier social stress test

Other: Trier social stress test

Interventions

Trier social stress testOTHER

Volunteers perform Trier social stress test

non-stressedstressed

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy men aged 19-35 years old

You may qualify if:

  • Man, 19-35 years old
  • Healthy

You may not qualify if:

  • Psychological disorders
  • Use of antibiotics or other drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, 221 00, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva Plasma/Serum

MeSH Terms

Interventions

Psychological Tests

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Caroline Linninge, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 30, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

SE(1)