Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg

Not Applicable

• Conditions: Pharmaconutrients; Critical Illness; Protein Metabolism
• Interventions: Dietary Supplement: 3hydroxybutyrate; Dietary Supplement: Vamin (Fresenius Kabi)

• Registration Number: NCT01461603
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2013-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• BMI between 19 and 28
• Written consent before study start

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Exclusion Criteria

• Diabetes
• Inclusion in other studies using ionizing radiation.
• Allergic to egg or soy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3hydroxybutyrat (3OHB)	3hydroxybutyrate	Ketone body, 3OHB compared to saline
Amino acids	Vamin (Fresenius Kabi)	Amino acids compared to saline

Primary Outcome Measures

Name	Time	Method
Changes in muscle metabolism after administration of amino acids.	Basal period and a glucose clamp (6 hours pr.day)	Measured by arterio-venous differences of isotope tracers

Secondary Outcome Measures

Name	Time	Method
Intracellular mTOR and pAkt signal activation after infusion of amino acids.	Basal period and a glucose clamp (6 hours pr. day)	4 muscle biopsies measured for mTOR and pAkt activation by western blotting

Trial Locations

Locations (1)

M-researchlab. MEA, Aarhus University Hospital, NBG; 🇩🇰 Aarhus C, Denmark