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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01461603
• Other study ID #: M-20110177
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2011
• Last updated: March 2, 2016
• Start date: September 2011
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Pharmaconutrients
• Protein Metabolism

Intervention

Dietary Supplement:
• Vamin (Fresenius Kabi)
Vamin 18gN 1ml/min infusion in 6 hours
• 3hydroxybutyrate
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Locations

Country	Name	City	State
Denmark	M-researchlab. MEA, Aarhus University Hospital, NBG	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in muscle metabolism after administration of amino acids.	Measured by arterio-venous differences of isotope tracers	Basal period and a glucose clamp (6 hours pr.day)	No
Secondary	Intracellular mTOR and pAkt signal activation after infusion of amino acids.	4 muscle biopsies measured for mTOR and pAkt activation by western blotting	Basal period and a glucose clamp (6 hours pr. day)	No