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The Effects of Amino Acid Supplement During Acute Inflammation.

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ClinicalTrials.gov Identifier: NCT01705782
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Nikolaj Fibiger Rittig, 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.


Condition or disease Intervention/treatment Phase
Febrile Illness Acute Inflammation Metabolic Diseases Biological: E. coli endotoxin, US standard Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Saline
Only saline is given.
Placebo Comparator: + Saline
Endotoxin is given + Placebo (Saline)
Biological: E. coli endotoxin, US standard
Active Comparator: + amino acids
Endotoxin is given + amino acids (intravenously)
Biological: E. coli endotoxin, US standard



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705782


Locations
Denmark
Medical Department MEA, NBG, Aarhus University Hospital
Aarhus C, Jylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus