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

March 2, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • M-researchlab. MEA, Aarhus University Hospital, NBG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amino acids
Amino acids compared to saline
Dietary supplement: Vamin (Fresenius Kabi)
Vamin 18gN 1ml/min infusion in 6 hours
Active Comparator: 3hydroxybutyrat (3OHB)
Ketone body, 3OHB compared to saline
Dietary supplement: 3hydroxybutyrate
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.
Other Names:
  • 3OHB, 3hydroxybutyric acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Niels Møller, Professor, Dr.Med., University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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