Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in muscle metabolism after administration of amino acids.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI between 19 and 28
- •Written consent before study start
Exclusion Criteria
- •Inclusion in other studies using ionizing radiation.
- •Allergic to egg or soy
Arms & Interventions
Amino acids
Amino acids compared to saline
Intervention: Vamin (Fresenius Kabi) (Dietary Supplement)
3hydroxybutyrat (3OHB)
Ketone body, 3OHB compared to saline
Intervention: 3hydroxybutyrate (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Intracellular mTOR and pAkt signal activation after infusion of amino acids.(Basal period and a glucose clamp (6 hours pr. day))