Effect of High Protein Diet in Stroke Patients With Low Muscle Mass

Study Overview
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Brief Summary
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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.

Official Title
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Effect of High Protein Diet in Stroke Patients With Low Muscle Mass

Conditions
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Ischemic Stroke, Diet, Healthy, Muscle Loss

Intervention / Treatment
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* Dietary Supplement: high protein diet
* Dietary Supplement: normal protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute ischemic stroke during hospitalization eGFR >30 urine albumin creatinine ratio < 30 mg/g urinary creatinine excretion rate (CER) < 1500g/day Exclusion Criteria: chronic kidney disease stage 4 or 5 (i.e. eGFR < 30) proteinuria (protein 1+ or more in urine routine) known impairment of functional status (mRS ≥ 2) prior to the index stroke refuse to participate in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein diet<br>received high protein diet, prescribed by dietitian | Dietary Supplement: high protein diet<br>* receive 1.8g protein/kg<br>|
| Active Comparator: Normal protein diet<br>received normal protein diet, prescribed by dietitian | Dietary Supplement: normal protein diet<br>* receive 1g protein/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale 0-1 | No significant disability | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale 0-2 | Slight disability | 3 months |