Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
NCT ID: NCT01461603
Last Updated: 2016-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2011-09-30
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Amino acids
Amino acids compared to saline
Vamin (Fresenius Kabi)
Vamin 18gN 1ml/min infusion in 6 hours
3hydroxybutyrat (3OHB)
Ketone body, 3OHB compared to saline
3hydroxybutyrate
Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written consent before study start
Exclusion Criteria
* Inclusion in other studies using ionizing radiation.
* Allergic to egg or soy
21 Years
50 Years
MALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Niels Møller, Professor, Dr.Med.
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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M-researchlab. MEA, Aarhus University Hospital, NBG
Aarhus C, , Denmark
Countries
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Other Identifiers
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M-20110177
Identifier Type: -
Identifier Source: org_study_id
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