Ischemic Stroke, Diet, Healthy, Muscle Loss
Conditions
Brief summary
Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient. Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events. We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER\<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.
Interventions
receive 1.8g protein/kg
receive 1g protein/kg
Sponsors
Study design
Eligibility
Inclusion criteria
1. acute ischemic stroke during hospitalization 2. eGFR \>30 3. urine albumin creatinine ratio \< 30 mg/g 4. urinary creatinine excretion rate (CER) \< 1500g/day
Exclusion criteria
1. chronic kidney disease stage 4 or 5 (i.e. eGFR \< 30) 2. proteinuria (protein 1+ or more in urine routine) 3. known impairment of functional status (mRS ≥ 2) prior to the index stroke 4. refuse to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale 0-1 | 3 months | No significant disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale 0-2 | 3 months | Slight disability |
Countries
Taiwan