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The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application

NCT ID: NCT00468507

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma

Keywords

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CCK release

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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nutritional intervention with Respifor and Diasip

Four nutritional interventions on four separate days per test person

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females
* 45 \> age \<55

Exclusion Criteria

* Gastrointestinal diseases
* Inflammatory conditions
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center

Principal Investigators

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Jan-Willem Greve, professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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University Maastricht

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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067030

Identifier Type: -

Identifier Source: org_study_id