The Effects of Amino Acid Supplement During Acute Inflammation.

Inflammation Clinical Trial

Official title:

Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705782
• Other study ID #: 2012-410-12
• Status: Completed
• Phase: N/A
• First received: October 8, 2012
• Last updated: November 11, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• male gender

• 20<BMI<30

• Age > 25 years old

• Written consent before starting the study

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Illness Acute
• Inflammation
• Metabolic Diseases

Intervention

Biological:
• E. coli endotoxin, US standard

Locations

Country	Name	City	State
Denmark	Medical Department MEA, NBG, Aarhus University Hospital	Aarhus C	Jylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein catabolism during acute illness	Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.	After 6 hours intervention	No
Secondary	The local effects on muscle and fat tissue	A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues.	At 2 hours and 4,5 hours	No
Secondary	Other systemic metabolic effects during acute illness	Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.	6 hours	No