Systemic Inflammatory Response SyndromeNCT01752348
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
A study testing Endotoxin, US standard reference E.coli in people with Systemic Inflammatory Response Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- What is being tested?
- Endotoxin, US standard reference E.coli
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Nov 2014
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 < body mass index < 30 kg/m2.
- written and orally informed consent before enrollment.
Who cannot join
- participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
- allergy to soy products or eggs
- diabetes, any type
- epilepsy
- ongoing infection
- immune deficiency
Show all 9Show fewer
- cardiovascular disease
- dysregulated hypertension
- primary muscles disease, congenital or acquired
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Laboratory, Department of Internal Medicine and Endocrinology
Aarhus C, 8000
About this study
Official title: Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals; a Study on Muscle Wasting and Metabolism During Acute Inflammation and Potential Anabolic Mechanisms.
The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.
- Conditions
- Systemic Inflammatory Response Syndrome
- Being tested
- Endotoxin, US standard reference E.coli
- Keywords
- sepsis, cytokine release, fever
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotoxin, US standard reference E.coliOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo (isotonic saline) | Placebo comparator | Endotoxin + isotonic saline. Reference for model of acute inflammatory illness Receives: Other: Endotoxin, US standard reference E.coli |
| Acipimox + Placebo (isotonic saline) | Experimental | Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis. Receives: Other: Endotoxin, US standard reference E.coli |
| Acipimox + free fatty acids | Experimental | Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids Receives: Other: Endotoxin, US standard reference E.coli |
| Acipimox + 3-hydroxybutyrate | Experimental | Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate Receives: Other: Endotoxin, US standard reference E.coli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein metabolism
Measurements of protein oxidation during intervention using radioactive tracer techniques.
Measured: 6 hours intervention period
Secondary outcomes (1)
Activated intracellular signalling pathways
Measurements on biopsies from muscle and fatty tissue taken on day of study
Measured: study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Professor, Principal investigator, Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752348
- Sponsor's protocol ID
- 11422796
- Other IDs
- 1-10-72-530-12
- Status last verified
- Jul 2013
- First submitted
- 14 Dec 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomsen HH, Rittig N, Johannsen M, Moller AB, Jorgensen JO, Jessen N, Moller N. Effects of 3-hydroxybutyrate and free fatty acids on muscle protein kinetics and signaling during LPS-induced inflammation in humans: anticatabolic impact of ketone bodies. Am J Clin Nutr. 2018 Oct 1;108(4):857-867. doi: 10.1093/ajcn/nqy170.
PubMed 30239561
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals; a Study on Muscle Wasting and Metabolism During Acute Inflammation and Potential Anabolic Mechanisms.
- ClinicalTrials.gov ID
- NCT01752348
- Acronym / sponsor ID
- 11422796
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- sepsis, cytokine release, fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Dec 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 investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (isotonic saline) | Placebo comparator | Other: Endotoxin, US standard reference E.coliEndotoxin + isotonic saline. Reference for model of acute inflammatory illness |
| Acipimox + Placebo (isotonic saline) | Experimental | Other: Endotoxin, US standard reference E.coliEndotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis. |
| Acipimox + free fatty acids | Experimental | Other: Endotoxin, US standard reference E.coliEndotoxin + Acipimox + free fatty acids. Intervention: free fatty acids |
| Acipimox + 3-hydroxybutyrate | Experimental | Other: Endotoxin, US standard reference E.coliEndotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20 < body mass index < 30 kg/m2.
- written and orally informed consent before enrollment.
Key exclusion criteria (9 listed)
- participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
- allergy to soy products or eggs
- diabetes, any type
- epilepsy
- ongoing infection
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 |
|---|---|---|
| Endotoxin, US standard reference E.coli | Other | Acipimox + 3-hydroxybutyrate, Acipimox + Placebo (isotonic saline), Acipimox + free fatty acids, Placebo (isotonic saline) |
Primary outcome
Protein metabolism
Time frame: 6 hours intervention period
Measurements of protein oxidation during intervention using radioactive tracer techniques.
1 secondary outcome
Activated intracellular signalling pathways
Time frame: study day
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 25 Nov 2014.
- Derived from this study: PubMed 30239561Thomsen HH, Rittig N, Johannsen M, Moller AB, Jorgensen JO, Jessen N, Moller N. Effects of 3-hydroxybutyrate and free fatty acids on muscle protein kinetics and signaling during LPS-induced inflammation in humans: anticatabolic impact of ketone bodies. Am J Clin Nutr. 2018 Oct 1;108(4):857-867. doi: 10.1093/ajcn/nqy170.
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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.
Niels Møller, Professor principal investigator
Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotoxin, US standard reference E.coli in people with Systemic Inflammatory Response Syndrome, 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 2 inclusion and 9 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 25 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 metabolism (time frame: 6 hours intervention period). 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 NCT01752348, which also lists 1 linked publication.
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 25 Nov 2014.