Back to resultsThe Effects of Amino Acid Supplement During Acute Inflammation.
Primary Purpose
Febrile Illness Acute, Inflammation, Metabolic Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
E. coli endotoxin, US standard
Sponsored by
About this trial
This is an interventional treatment trial for Febrile Illness Acute
Eligibility 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.
Sites / Locations
- Medical Department MEA, NBG, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Active Comparator
Arm Label
Saline
+ Saline
+ amino acids
Arm Description
Only saline is given.
Endotoxin is given + Placebo (Saline)
Endotoxin is given + amino acids (intravenously)
Outcomes
Primary Outcome Measures
Protein catabolism during acute illness
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
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
Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
Full Information
NCT ID
NCT01705782
First Posted
October 8, 2012
Last Updated
November 11, 2014
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT01705782
Brief Title
The Effects of Amino Acid Supplement During Acute Inflammation.
Official Title
Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Illness Acute, Inflammation, Metabolic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
No Intervention
Arm Description
Only saline is given.
Arm Title
+ Saline
Arm Type
Placebo Comparator
Arm Description
Endotoxin is given + Placebo (Saline)
Arm Title
+ amino acids
Arm Type
Active Comparator
Arm Description
Endotoxin is given + amino acids (intravenously)
Intervention Type
Biological
Intervention Name(s)
E. coli endotoxin, US standard
Primary Outcome Measure Information:
Title
Protein catabolism during acute illness
Description
Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
Time Frame
After 6 hours intervention
Secondary Outcome Measure Information:
Title
The local effects on muscle and fat tissue
Description
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
Title
Other systemic metabolic effects during acute illness
Description
Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
Time Frame
6 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Medical Department MEA, NBG, Aarhus University Hospital
City
Aarhus C
State/Province
Jylland
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
35883493
Citation
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.
Results Reference
derived
PubMed Identifier
27627109
Citation
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.
Results Reference
derived
PubMed Identifier
25896101
Citation
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.
Results Reference
derived
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The Effects of Amino Acid Supplement During Acute Inflammation.
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