NCT01705782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

October 8, 2012

Last Update Submit

November 11, 2014

Conditions

Febrile Illness AcuteInflammationMetabolic Diseases

Outcome Measures

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.

    After 6 hours intervention

Secondary Outcomes (2)

  • The local effects on muscle and fat tissue

    At 2 hours and 4,5 hours

  • Other systemic metabolic effects during acute illness

    6 hours

Study Arms (3)

Saline

NO INTERVENTION

Only saline is given.

+ Saline

PLACEBO COMPARATOR

Endotoxin is given + Placebo (Saline)

Biological: E. coli endotoxin, US standard

+ amino acids

ACTIVE COMPARATOR

Endotoxin is given + amino acids (intravenously)

Biological: E. coli endotoxin, US standard

Interventions

E. coli endotoxin, US standardBIOLOGICAL
+ Saline+ amino acids

Eligibility Criteria

Age25 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department MEA, NBG, Aarhus University Hospital

Aarhus C, Jylland, 8000, Denmark

Location

Related Publications (4)

  • Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14.

    PMID: 37844838DERIVED

  • 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.

    PMID: 35883493DERIVED

  • 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.

    PMID: 27627109DERIVED

  • 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.

    PMID: 25896101DERIVED

MeSH Terms

Conditions

InflammationMetabolic Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD (medical graduate) and Ph.d.-student

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 12, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

DK(1)