NCT00468507

Brief Summary

Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor. In this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2007

Typical duration for early_phase_1

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

2.9 years

First QC Date

May 1, 2007

Last Update Submit

March 30, 2010

Conditions

Trauma

Keywords

CCK release

Outcome Measures

Primary Outcomes (1)

  • CCK-release

    two hours

Interventions

nutritional intervention with Respifor and DiasipDIETARY_SUPPLEMENT

Four nutritional interventions on four separate days per test person

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females
  • \> age \<55

You may not qualify if:

  • Gastrointestinal diseases
  • Inflammatory conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Maastricht

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Jan-Willem Greve, professor

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 2, 2007

Study Start

March 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

NL(1)