Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Protein catabolism during acute illness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •* male gender
- •* 20\ 25 years old
- •* Written consent before starting the study
Exclusion Criteria
- •Allergy for soya products ore egg
- •Infection
- •Immune defects
- •Heart disease
- •Dysregulated hypertension
- •Participating in other trials using radioactive tracers or x-rays the last year.
Arms & Interventions
+ amino acids
Endotoxin is given + amino acids (intravenously)
Intervention: E. coli endotoxin, US standard (Biological)
+ Saline
Endotoxin is given + Placebo (Saline)
Intervention: E. coli endotoxin, US standard (Biological)
Saline
Only saline is given.
Outcomes
Primary Outcomes
Protein catabolism during acute illness
Time Frame: After 6 hours intervention
Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
Secondary Outcomes
- Other systemic metabolic effects during acute illness(6 hours)
- The local effects on muscle and fat tissue(At 2 hours and 4,5 hours)
Investigators
Nikolaj Fibiger Rittig
MD (medical graduate) and Ph.d.-student
University of Aarhus