Critical IllnessNCT01461603
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
A study testing Vamin (Fresenius Kabi) and 3hydroxybutyrate in people with Critical Illness and Protein Metabolism, run by University of Aarhus at 1 site in Denmark.
Trial summary
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Protein Metabolism, Pharmaconutrients
- What is being tested?
- Vamin (Fresenius Kabi) and 3hydroxybutyrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Jul 2016
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 19 and 28
- Written consent before study start
- Allergic to egg or soy
Who cannot join
- Diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
M-researchlab. MEA, Aarhus University Hospital, NBG
Aarhus C, 8000
About this study
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.
Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.
Read more
Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.
Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.
- Conditions
- Critical Illness, Protein Metabolism, Pharmaconutrients
- Being tested
- Vamin (Fresenius Kabi), 3hydroxybutyrate
- Keywords
- critical illness, protein metabolism, pharmaconutrients
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vamin (Fresenius Kabi)Dietary supplement
Vamin 18gN 1ml/min infusion in 6 hours
3hydroxybutyrateDietary supplement
Also called 3OHB, 3hydroxybutyric acid
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Amino acids | Active comparator | Amino acids compared to saline Receives: Dietary Supplement: Vamin (Fresenius Kabi) |
| 3hydroxybutyrat (3OHB) | Active comparator | Ketone body, 3OHB compared to saline Receives: Dietary Supplement: 3hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle metabolism after administration of amino acids.
Measured by arterio-venous differences of isotope tracers
Measured: Basal period and a glucose clamp (6 hours pr.day)
Secondary outcomes (1)
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
4 muscle biopsies measured for mTOR and pAkt activation by western blotting
Measured: Basal period and a glucose clamp (6 hours pr. day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- 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, Dr.Med., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461603
- Sponsor's protocol ID
- M-20110177
- Status last verified
- Jan 2016
- First submitted
- 19 Oct 2011
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
- ClinicalTrials.gov ID
- NCT01461603
- Acronym / sponsor ID
- M-20110177
- Conditions
- Critical Illness, Protein Metabolism, Pharmaconutrients
- Keywords
- critical illness, protein metabolism, pharmaconutrients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Oct 2011 (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.
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.
Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.
Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.
Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acids | Active comparator | Dietary Supplement: Vamin (Fresenius Kabi)Amino acids compared to saline |
| 3hydroxybutyrat (3OHB) | Active comparator | Dietary Supplement: 3hydroxybutyrateKetone body, 3OHB compared to saline |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 19 and 28
- Written consent before study start
- Allergic to egg or soy
Key exclusion criteria (1 listed)
- Diabetes
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 |
|---|---|---|
| Vamin (Fresenius Kabi)Vamin 18gN 1ml/min infusion in 6 hours | Dietary supplement | Amino acids |
| 3hydroxybutyrateAlso: 3OHB, 3hydroxybutyric acidGoldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy. | Dietary supplement | 3hydroxybutyrat (3OHB) |
Primary outcome
Changes in muscle metabolism after administration of amino acids.
Time frame: Basal period and a glucose clamp (6 hours pr.day)
Measured by arterio-venous differences of isotope tracers
1 secondary outcome
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
Time frame: Basal period and a glucose clamp (6 hours pr. day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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, Dr.Med. principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vamin (Fresenius Kabi) and 3hydroxybutyrate in people with Critical Illness and Protein Metabolism, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2016. 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. 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?
Results are not available in the source record.
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?
Changes in muscle metabolism after administration of amino acids. (time frame: Basal period and a glucose clamp (6 hours pr.day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2016.