Local Effects of Amino Acids, Leucine and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critical Illness; Protein Metabolism; Pharmaconutrients
Intervention: Vamin (Fresenius Kabi) (Dietary Supplement); Amino acids enriched with 3-hydroxybutyrate, leucine or both. Not yet specified. (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Niels Møller, Professor, Dr.Med., Principal Investigator, Affiliation: University of Aarhus
Overall contact:
Jonas F Olesen, BSc.med, Phone: +45 20667966, Email: jonas.franck.olesen@hotmail.com
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%. Animal
studies also show that after administrating 3-hydroxybutyrate (3-OHB), cardiac output
increase, and O2 consumption decrease. Humane studies show 10% increase in protein synthesis
and 30% decrease in protein degradation after administration of 3-OHB.
Objectives: Compared to saline, an amino acid 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 be further amplified by leucine
and 3-OHB enrichment and will include distinct alterations in muscle signal events, in
particular mTOR.
Methods: n = 4 x 8 healthy male subjects are equipped with catheters in aa. femorales and
vv. femorales bilaterally under local anaesthetics. Each study comprises a 3-hour basal
period and a 3-hour period with hyperinsulinaemic-euglucaemic clamp. During the test,
samples of arterial and venous blood and 4 muscle biopsies are obtained. The 4 different
studies contain continues saline infusion compared to either (i) amino acids (Vamin), (ii)
Vamin + leucine, (iii) Vamin + 3-OHB or (iiii) Vamin + leucine + 3-OHB.
Perspectives: This study elucidates whether infusion of aminoacids, leucin and
3-hydroxybutyrate can diminish protein loss and thereby potentially improve the nutrition of
all critically ill patients.
Clinical Details
Official title: Local Effects of Amino Acids, Leucine and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Changes in muscle metabolism after administration of amino acids.Changes in muscle metabolism after administration of amino acids enriched with leucine Changes in muscle metabolism after administration of amino acids enriched with 3-OHB Changes in muscle metabolism after administration of amino acids enriched with leucine and 3OHB
Secondary outcome: Intracellular mTOR signal activation after infusion of amino acids, leucine and 3-OHB
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
Jonas F Olesen, BSc.med, Phone: +45 20667966, Email: jonas.franck.olesen@hotmail.com
M-researchlab. MEA, Aarhus University Hospital, NBG, Aarhus C 8000, Denmark; Recruiting
Niels Møller, Proffessor, Dr.med, Phone: +45 80492165, Email: nielsem@dadlnet.dk
Jonas Franck Olesen, BSc.med, Sub-Investigator
Ermina Bosnjak, MD, Sub-Investigator
Niels Møller, Professor, Doctor Med, Principal Investigator
Additional Information
Starting date: September 2011
Last updated: May 1, 2012
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