NCT01461603

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Male
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Critical Illness
• Protein Metabolism
• Pharmaconutrients

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-02-01
• Completion: 2016-07-01
• First posted: 2011-10-28
• Last updated: 2016-03-03

Locations

1 site across 1 country: Denmark