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

NCT01461603 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-03-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Møller, Professor, Dr.Med. · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-02-28
Completion
2016-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461603 on ClinicalTrials.gov