COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Effects of Amino Acid Supplement During Acute Inflammation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01705782
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : November 13, 2014
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

Layout table for study information
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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT01705782

Layout table for location information
Medical Department MEA, NBG, Aarhus University Hospital
Aarhus C, Jylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nikolaj Fibiger Rittig, MD (medical graduate) and Ph.d.-student, University of Aarhus Identifier: NCT01705782    
Other Study ID Numbers: 2012-410-12
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases
Pathologic Processes