Inflammation Clinical Trial
Official title:
Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Medical Department MEA, NBG, Aarhus University Hospital | Aarhus C | Jylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
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 |
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