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Local Effects of Amino Acids in the Bilaterally Perfused Human Leg

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Critical Illness; Protein Metabolism; Pharmaconutrients

Intervention: Vamin (Fresenius Kabi) (Dietary Supplement)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Niels Møller, Professor, Dr.Med., Principal Investigator, Affiliation: University of Aarhus

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 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 = 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 intervention contain continues saline infusion compared to either amino acids (Vamin). Perspectives: This study elucidates the direct effect of aminoacids on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.

Clinical Details

Official title: Local Effects of Amino Acids 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.

Secondary outcome: Intracellular mTOR and pAkt signal activation after infusion of amino acids.

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

M-researchlab. MEA, Aarhus University Hospital, NBG, Aarhus C 8000, Denmark
Additional Information

Starting date: September 2011
Last updated: August 5, 2013

Page last updated: August 23, 2015

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