Table 1 Inclusion and exclusion criteria of the AMINO-Stroke

Inclusion criteria:

• Patient >45 years

• Patients with ischemic or haemorrhagic stroke within 8 weeks to enrolment

• Brain magnet resonance imaging or computer tomography demonstrating stroke

• Motoric disability of an upper and /or lower limb (Rivermead Motor Assessment Gross Function > 1 and <11)

• Signed informed consent

Exclusion criteria:

• Clinically significant findings on physical examination or presence of clinically significant disease that would interfere with study evaluation in the opinion of the treating physicians

• Participation in another clinical trial investigating a nutritional product

• History of intolerance or allergic response to similar nutritional products or known hypersensitivity to essential amino acids

• Clinical sighs and symptoms of infection requiring antibiotic therapy at the time of enrolment that prevent completion of trial-related assessments as judged by the investigator

• Transaminases (AST or ALT) > 3 times the upper limit of normal (ULN)

• Severe renal dysfunction or nephrotic syndrome

• Acquired immunodeficiency syndrome, HIV or Hepatitis C infection

• Current therapy with anabolic steroids or appetite stimulants

• Current immunosuppressive therapy, heart transplantation, or renal dialysis

• Life expectancy < 6 months