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

NCT01461603 | Unknown DMC

• 1 other identifier: M-20110177
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Protein Metabolism; Pharmaconutrients

Keywords

critical illness; protein metabolism; pharmaconutrients

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Intracellular mTOR and pAkt signal activation after infusion of amino acids.

  Basal period and a glucose clamp (6 hours pr. day)

Study Arms (2)

Amino acids

ACTIVE COMPARATOR

Amino acids compared to saline

Dietary Supplement: Vamin (Fresenius Kabi)

3hydroxybutyrat (3OHB)

ACTIVE COMPARATOR

Ketone body, 3OHB compared to saline

Dietary Supplement: 3hydroxybutyrate

Interventions

Vamin (Fresenius Kabi) DIETARY_SUPPLEMENT

Vamin 18gN 1ml/min infusion in 6 hours

Amino acids

3hydroxybutyrate DIETARY_SUPPLEMENT

Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Also known as: 3OHB, 3hydroxybutyric acid

3hydroxybutyrat (3OHB)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Diabetes
• Allergic to egg or soy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

M-researchlab. MEA, Aarhus University Hospital, NBG

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Critical Illness

Interventions

amino-acid, glucose, and electrolyte solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels Møller, Professor, Dr.Med.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 28, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-01

Locations

DK (1)