ClinicalTrials.Veeva

Menu

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

University of Aarhus logo

University of Aarhus

Status

Unknown

Conditions

Protein Metabolism
Critical Illness
Pharmaconutrients

Treatments

Dietary Supplement: Vamin (Fresenius Kabi)
Dietary Supplement: 3hydroxybutyrate

Study type

Interventional

Funder types

Other

Identifiers

NCT01461603
M-20110177

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

Amino acids
Active Comparator group
Description:
Amino acids compared to saline
Treatment:
Dietary Supplement: Vamin (Fresenius Kabi)
3hydroxybutyrat (3OHB)
Active Comparator group
Description:
Ketone body, 3OHB compared to saline
Treatment:
Dietary Supplement: 3hydroxybutyrate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems