I63.5 I63.8
Conditions
Interventions
Group 1: oral administration of 12 g essential amino acids/day for 4 weeks
Group 2: Control intervention:
oral administration of matching placebo for 4 weeks
Sponsors
Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent • Age = 55 years • Patients admitted to in-hospital rehabilitation after acute stroke • Ischemic stroke of the anterior (ACA, MCA) or posterior (PCA, BA) territory prior ( 1 and < 11
Exclusion criteria
Exclusion criteria: • Clinically significant findings on physical examination or presence of known 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 signs and symptoms of infection requiring antibiotic therapy at the time of enrolment that prevent adequate completion of trial related assessments as judged by the investigator • Liver transaminases (AST or ALT) > 3 times the upper limit of normal (ULN), or severe renal dysfunction or nephrotic syndrome • Known 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of essential amino acids supplementation on 1) physical performance (Rivermead Motor Assessment Gross Function) and 2) muscle strength (handgrip) in patients with stroke after 4 weeks of dietary supplementation with essential amino acids Parameters are measured in both groups (Aminoacid-treatment and placebo group) time point 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| All parameters were analyzed at the begining of the study and after 4 weeks of treatment. • To evaluate the effect of essential amino acids on health-related quality of life in patients 3 months after stroke (EQ-5D, PGA, SF36) To assess the effect of essential amino acids compared with placebo: • On stroke related disability and functional independence (Barthel-Index, modified Rankin Scale) of patients at the end of in-hospital rehabilitation after stroke • On stroke related disability and functional independence (Barthel-Index, modified Rankin Scale) of patients at 3 months after stroke • On functional rehabilitation success (pinch strength, motor assessment scale, Fugl-Meyer Score (motor functional domain), functional ambulatory category (FAC), short physical performance battery test) • On body composition changes and the development of cachexia in the course of post stroke rehabilitation • On insulin sensitivity in the course post stroke rehabilitation • On nutritional status and metabolic profile in the course of post stroke rehabilitation • On number, rate and duration of hospitalizations for any reason • On development of post stroke infection • On development of any stroke related complication • To evaluate the tolerability and safety of essential amino acids: Safety endpoints for tolerability will include recording of adverse events and serious adverse events during follow-up. | — |
Countries
Germany
Contacts
Public ContactWolfram Doehner
Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
Outcome results
None listed