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The Effects of Amino Acid Supplement During Acute Inflammation.

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University of Aarhus

Status

Completed

Conditions

Metabolic Diseases
Inflammation
Febrile Illness Acute

Treatments

Biological: E. coli endotoxin, US standard

Study type

Interventional

Funder types

Other

Identifiers

NCT01705782
2012-410-12

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

8 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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