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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

Page last updated: February 07, 2013

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