NCT04295044

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke
• Diet, Healthy
• Muscle Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	high protein diet	receive 1.8g protein/kg
DIETARY_SUPPLEMENT	normal protein diet	receive 1g protein/kg

Timeline

• Start date: 2017-12-15
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2020-03-04
• Last updated: 2023-03-30

Locations

1 site across 1 country: Taiwan