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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01461603
Other study ID # M-20110177
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 19, 2011
Last updated March 2, 2016
Start date September 2011
Est. completion date July 2016

Study information

Verified date January 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date July 2016
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vamin (Fresenius Kabi)
Vamin 18gN 1ml/min infusion in 6 hours
3hydroxybutyrate
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Locations

Country Name City State
Denmark M-researchlab. MEA, Aarhus University Hospital, NBG Aarhus C

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Intracellular mTOR and pAkt signal activation after infusion of amino acids. 4 muscle biopsies measured for mTOR and pAkt activation by western blotting Basal period and a glucose clamp (6 hours pr. day) No
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