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

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ClinicalTrials.gov Identifier: NCT01461603
Recruitment Status : Unknown
Verified January 2016 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Critical Illness Protein Metabolism Pharmaconutrients Dietary Supplement: Vamin (Fresenius Kabi) Dietary Supplement: 3hydroxybutyrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Study Start Date : September 2011
Actual Primary Completion Date : February 2013
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: 3OHB, 3hydroxybutyric acid




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461603


Locations
Denmark
M-researchlab. MEA, Aarhus University Hospital, NBG
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Niels Møller, Professor, Dr.Med. University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01461603     History of Changes
Other Study ID Numbers: M-20110177
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: January 2016

Keywords provided by University of Aarhus:
critical illness
protein metabolism
pharmaconutrients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes