The Effects of Amino Acid Supplement During Acute Inflammation.
NCT ID: NCT01705782
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2012-10-31
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Saline
Only saline is given.
No interventions assigned to this group
+ Saline
Endotoxin is given + Placebo (Saline)
E. coli endotoxin, US standard
+ amino acids
Endotoxin is given + amino acids (intravenously)
E. coli endotoxin, US standard
Interventions
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E. coli endotoxin, US standard
Eligibility Criteria
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Inclusion Criteria
* 20\<BMI\<30
* Age \> 25 years old
* Written consent before starting the study
Exclusion Criteria
* Diabetes
* Epilepsy
* Infection
* Immune defects
* Heart disease
* Dysregulated hypertension
* Participating in other trials using radioactive tracers or x-rays the last year.
25 Years
MALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Nikolaj Fibiger Rittig
MD (medical graduate) and Ph.d.-student
Locations
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Medical Department MEA, NBG, Aarhus University Hospital
Aarhus C, Jylland, Denmark
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2012-410-12
Identifier Type: -
Identifier Source: org_study_id