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The Anti-Inflammatory Effects of High-Fat Nutrition; Towards a Clinical Application
This study is currently recruiting participants.
Verified by Maastricht University Medical Center, May 2009
First Received: May 1, 2007   Last Updated: May 5, 2009   History of Changes
Sponsored by: Maastricht University Medical Center
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00468507
  Purpose

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 Intervention Phase
Trauma
Dietary Supplement: nutritional intervention with Respifor and Diasip
Phase 0

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment
Official Title: The Anti-Inflammatory Effects of High-Fat Nutrition; Towards a Clinical Application

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • CCK-release [ Time Frame: two hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: nutritional intervention with Respifor and Diasip
    Four nutritional interventions on four separate days per test person
  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females
  • 45 > age <55

Exclusion Criteria:

  • Gastrointestinal diseases
  • Inflammatory conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468507

Contacts
Contact: Tim Lubbers, PhD-student 0433882128 ext 0031 t.lubbers@ah.unimaas.nl

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

No publications provided

Responsible Party: Maastricht University Medical Center ( J.W.M. Greve, MD, PhD )
Study ID Numbers: 067030
Study First Received: May 1, 2007
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00468507     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
CCK release

Study placed in the following topic categories:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 06, 2009