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CompletedNCT01705782Updated Nov 13, 2014

The Effects of Amino Acid Supplement During Acute Inflammation.

An interventional study of E. coli endotoxin, US standard in Febrile Illness Acute, Inflammation and Metabolic Diseases, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
25 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Febrile Illness Acute
  • Inflammation
  • Metabolic Diseases
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 8 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • male gender
  • 20\<BMI\<30
  • Age > 25 years old
  • Written consent before starting the study

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalE. coli endotoxin, US standard
06

What researchers measure

Primary outcomes

  1. Protein catabolism during acute illness

    Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.

    Time frame: After 6 hours intervention

Secondary outcomes

  1. 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.

    Time frame: At 2 hours and 4,5 hours

  2. Other systemic metabolic effects during acute illness

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

    Time frame: 6 hours

07

Study locations

1 site
  • Medical Department MEA, NBG, Aarhus University Hospital
    Aarhus C, Jylland 8000, Denmark
08

References and documents

Publications

  • Vladimirova YV, Molmer MK, Antonsen KW, Moller N, Rittig N, Nielsen MC, Moller HJ. A New Serum Macrophage Checkpoint Biomarker for Innate Immunotherapy: Soluble Signal-Regulatory Protein Alpha (sSIRPalpha). Biomolecules. 2022 Jul 4;12(7):937. doi: 10.3390/biom12070937. PubMed 35883493 ↗
  • Rittig N, Bach E, Thomsen HH, Pedersen SB, Nielsen TS, Jorgensen JO, Jessen N, Moller N. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial. PLoS One. 2016 Sep 14;11(9):e0162167. doi: 10.1371/journal.pone.0162167. eCollection 2016. PubMed 27627109 ↗
  • Rittig N, Bach E, Thomsen HH, Johannsen M, Jorgensen JO, Richelsen B, Jessen N, Moller N. Amino acid supplementation is anabolic during the acute phase of endotoxin-induced inflammation: A human randomized crossover trial. Clin Nutr. 2016 Apr;35(2):322-330. doi: 10.1016/j.clnu.2015.03.021. Epub 2015 Apr 9. PubMed 25896101 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01705782
Lead sponsor
University of Aarhus
Responsible party
Nikolaj Fibiger Rittig (MD (medical graduate) and Ph.d.-student, University of Aarhus) — Principal investigator
First posted
Oct 12, 2012
Start date
Oct 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Nov 13, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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