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

Phase 2

Completed

• Conditions: Ischemic Stroke; Diet, Healthy; Muscle Loss
• Interventions: Dietary Supplement: normal protein diet; Dietary Supplement: high protein diet

• 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

Arm && Interventions

Group	Intervention	Description
Normal protein diet	normal protein diet	received normal protein diet, prescribed by dietitian
High protein diet	high protein diet	received high protein diet, prescribed by dietitian

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