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

Phase 2

Completed

• Conditions: Ischemic Stroke; Diet, Healthy; Muscle Loss

• Registration Number: NCT04295044
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale 0-1	3 months	No significant disability

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale 0-2	3 months	Slight disability

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Chiayi Branch; 🇨🇳 Chiayi City, Taiwan