Overview

This trial is active, not recruiting.

Conditions critical illness, protein metabolism, pharmaconutrients
Treatments vamin (fresenius kabi), 3hydroxybutyrate
Sponsor University of Aarhus
Start date September 2011
End date February 2013
Trial size 10 participants
Trial identifier NCT01461603, M-20110177

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
Amino acids compared to saline
vamin (fresenius kabi)
Vamin 18gN 1ml/min infusion in 6 hours
(Active Comparator)
Ketone body, 3OHB compared to saline
3hydroxybutyrate 3OHB, 3hydroxybutyric acid
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Primary Outcomes

Measure
Changes in muscle metabolism after administration of amino acids.
time frame: Basal period and a glucose clamp (6 hours pr.day)

Secondary Outcomes

Measure
Intracellular mTOR and pAkt signal activation after infusion of amino acids.
time frame: Basal period and a glucose clamp (6 hours pr. day)

Eligibility Criteria

Male participants from 21 years up to 50 years old.

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

Additional Information

Official title Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Principal investigator Niels Møller, Professor, Dr.Med.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.