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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00468507
First received: May 1, 2007
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

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

Enrollment: 18
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: February 2010 (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

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
  More Information

No publications provided

Responsible Party: J.W.M. Greve, MD, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00468507     History of Changes
Other Study ID Numbers: 067030
Study First Received: May 1, 2007
Last Updated: March 30, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
CCK release

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013