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Completed

NCT Number: NCT01705782

The Effects of Amino Acid Supplement During Acute Inflammation.

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.

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Key information

Conditions

Febrile Illness Acute Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical Department MEA, NBG, Aarhus University Hospital

Aarhus C, Jylland, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E. coli endotoxin, US standard

Biological

Primary outcomes

  1. 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

  1. The local effects on muscle and fat tissue

    Time frame: 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.

  2. Other systemic metabolic effects during acute illness

    Time frame: 6 hours

    Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 12, 2012
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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