The Effects of Amino Acid Supplement During Acute Inflammation.

Not Applicable

Completed

• Conditions: Inflammation; Metabolic Diseases; Febrile Illness Acute
• Interventions: Biological: E. coli endotoxin, US standard

• Registration Number: NCT01705782
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.

E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.

The study is an interventional randomized placebo study including 8 healthy male subjects. Each subject participates 3 times (different days) and are given one of following interventions:

* Placebo (NaCl)

* Endotoxin, US standard reference E.Coli + Placebo (NaCl)

* Endotoxin, US standard reference E.Coli + Amino acids (intravenously)

It is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• male gender
• 20<BMI<30
• Age > 25 years old
• Written consent before starting the study

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Exclusion Criteria

• Allergy for soya products ore egg
• Diabetes
• Epilepsy
• Infection
• Immune defects
• Heart disease
• Dysregulated hypertension
• Participating in other trials using radioactive tracers or x-rays the last year.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
+ amino acids	E. coli endotoxin, US standard	Endotoxin is given + amino acids (intravenously)
+ Saline	E. coli endotoxin, US standard	Endotoxin is given + Placebo (Saline)

Primary Outcome Measures

Name	Time	Method
Protein catabolism during acute illness	After 6 hours intervention	Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.

Secondary Outcome Measures

Name	Time	Method
Other systemic metabolic effects during acute illness	6 hours	Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
The local effects on muscle and fat tissue	At 2 hours and 4,5 hours	A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues.

Trial Locations

Locations (1)

Medical Department MEA, NBG, Aarhus University Hospital; 🇩🇰 Aarhus C, Jylland, Denmark