Febrile Illness AcuteNCT01705782
The Effects of Amino Acid Supplement During Acute Inflammation.
A study testing E. coli endotoxin, US standard in people with Febrile Illness Acute and Inflammation, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Febrile Illness Acute, Inflammation, Metabolic Diseases
- What is being tested?
- E. coli endotoxin, US standard
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender
- 20<BMI<30
- Age > 25 years old
- Written consent before starting the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Medical Department MEA, NBG, Aarhus University Hospital
Aarhus C, Jylland, 8000
About this study
Official title: Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.
- Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.
Read more
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.
- Conditions
- Febrile Illness Acute, Inflammation, Metabolic Diseases
- Being tested
- E. coli endotoxin, US standard
- Medical subject headings
- Inflammation, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli endotoxin, US standardBiological
| Study group | Role | What they receive |
|---|---|---|
| Saline | No intervention | Only saline is given. |
| + Saline | Placebo comparator | Endotoxin is given + Placebo (Saline) Receives: Biological: E. coli endotoxin, US standard |
| + amino acids | Active comparator | Endotoxin is given + amino acids (intravenously) Receives: Biological: E. coli endotoxin, US standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein catabolism during acute illness
Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
Measured: After 6 hours intervention
Secondary outcomes (2)
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.
Measured: At 2 hours and 4,5 hours
Other systemic metabolic effects during acute illness
Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Febrile Illness AcuteStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Fibiger Rittig, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705782
- Sponsor's protocol ID
- 2012-410-12
- Status last verified
- Nov 2014
- First submitted
- 8 Oct 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37844838Vladimirova 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 35883493Rittig 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 27627109Rittig 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
- ClinicalTrials.gov ID
- NCT01705782
- Acronym / sponsor ID
- 2012-410-12
- Conditions
- Febrile Illness Acute, Inflammation, Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | No intervention | –Only saline is given. |
| + Saline | Placebo comparator | Biological: E. coli endotoxin, US standardEndotoxin is given + Placebo (Saline) |
| + amino acids | Active comparator | Biological: E. coli endotoxin, US standardEndotoxin is given + amino acids (intravenously) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male gender
- 20<BMI<30
- Age > 25 years old
- Written consent before starting the study
Key exclusion criteria (8 listed)
- Allergy for soya products ore egg
- Diabetes
- Epilepsy
- Infection
- Immune defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E. coli endotoxin, US standard | Biological | + Saline, + amino acids |
Primary outcome
Protein catabolism during acute illness
Time frame: After 6 hours intervention
Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
2 secondary outcomes
The local effects on muscle and fat tissue
Time frame: At 2 hours and 4,5 hours
Other systemic metabolic effects during acute illness
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Derived from this study: PubMed 37844838Pedersen 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.
- Derived from this study: PubMed 35883493Vladimirova 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.
- Derived from this study: PubMed 27627109Rittig 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.
- Derived from this study: PubMed 25896101Rittig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E. coli endotoxin, US standard in people with Febrile Illness Acute and Inflammation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein catabolism during acute illness (time frame: After 6 hours intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705782, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.