Text Size

The Effects of Amino Acid Supplement During Acute Inflammation.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nikolaj Fibiger Rittig, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01705782
First received: October 8, 2012
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Febrile Illness Acute
Inflammation
Metabolic Diseases
 Biological: E. coli endotoxin, US standard

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Protein catabolism during acute illness [ Time Frame: After 6 hours intervention ] [ Designated as safety issue: No ]
    Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.


Secondary Outcome Measures:
  • The local effects on muscle and fat tissue [ Time Frame: At 2 hours and 4,5 hours ] [ Designated as safety issue: No ]
    A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues.

  • Other systemic metabolic effects during acute illness [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.


Estimated Enrollment: 8
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705782

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

No publications provided

Responsible Party: Nikolaj Fibiger Rittig, MD (medical graduate) and Ph.d.-student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01705782     History of Changes
Other Study ID Numbers: 2012-410-12
Study First Received: October 8, 2012
Last Updated: February 11, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Inflammation
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013