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

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ClinicalTrials.gov Identifier: NCT00468507
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Trauma Dietary Supplement: nutritional intervention with Respifor and Diasip Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application
Study Start Date : March 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Intervention Details:
  • Dietary Supplement: nutritional intervention with Respifor and Diasip
    Four nutritional interventions on four separate days per test person


Primary Outcome Measures :
  1. CCK-release [ Time Frame: two hours ]


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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females
  • 45 > age <55

Exclusion Criteria:

  • Gastrointestinal diseases
  • Inflammatory conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468507


Locations
Netherlands
University Maastricht
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Jan-Willem Greve, professor Maastricht University Medical Center

Responsible Party: J.W.M. Greve, MD, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00468507     History of Changes
Other Study ID Numbers: 067030
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Maastricht University Medical Center:
CCK release

Additional relevant MeSH terms:
Anti-Inflammatory Agents