Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Primary Purpose
Critical Illness, Protein Metabolism, Pharmaconutrients
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vamin (Fresenius Kabi)
3hydroxybutyrate
Sponsored by

About this trial
This is an interventional treatment trial for Critical Illness focused on measuring critical illness, protein metabolism, pharmaconutrients
Eligibility Criteria
Inclusion Criteria:
- BMI between 19 and 28
- Written consent before study start
Exclusion Criteria:
- Diabetes
- Inclusion in other studies using ionizing radiation.
- Allergic to egg or soy
Sites / Locations
- M-researchlab. MEA, Aarhus University Hospital, NBG
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Amino acids
3hydroxybutyrat (3OHB)
Arm Description
Amino acids compared to saline
Ketone body, 3OHB compared to saline
Outcomes
Primary Outcome Measures
Changes in muscle metabolism after administration of amino acids.
Measured by arterio-venous differences of isotope tracers
Secondary Outcome Measures
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
4 muscle biopsies measured for mTOR and pAkt activation by western blotting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01461603
Brief Title
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Official Title
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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%.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Protein Metabolism, Pharmaconutrients
Keywords
critical illness, protein metabolism, pharmaconutrients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amino acids
Arm Type
Active Comparator
Arm Description
Amino acids compared to saline
Arm Title
3hydroxybutyrat (3OHB)
Arm Type
Active Comparator
Arm Description
Ketone body, 3OHB compared to saline
Intervention Type
Dietary Supplement
Intervention Name(s)
Vamin (Fresenius Kabi)
Intervention Description
Vamin 18gN 1ml/min infusion in 6 hours
Intervention Type
Dietary Supplement
Intervention Name(s)
3hydroxybutyrate
Other Intervention Name(s)
3OHB, 3hydroxybutyric acid
Intervention Description
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.
Primary Outcome Measure Information:
Title
Changes in muscle metabolism after administration of amino acids.
Description
Measured by arterio-venous differences of isotope tracers
Time Frame
Basal period and a glucose clamp (6 hours pr.day)
Secondary Outcome Measure Information:
Title
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
Description
4 muscle biopsies measured for mTOR and pAkt activation by western blotting
Time Frame
Basal period and a glucose clamp (6 hours pr. day)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI between 19 and 28
Written consent before study start
Exclusion Criteria:
Diabetes
Inclusion in other studies using ionizing radiation.
Allergic to egg or soy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Professor, Dr.Med.
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
M-researchlab. MEA, Aarhus University Hospital, NBG
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
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