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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468507
• Other study ID #: 067030
• Status: Completed
• Phase: Phase 0
• First received: May 1, 2007
• Last updated: March 30, 2010
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males and females

• 45 > age <55

Exclusion Criteria:

• Gastrointestinal diseases

• Inflammatory conditions

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Maastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCK-release		two hours	No