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

NCT ID: NCT04295044

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2021-03-31

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.

Conditions

Ischemic Stroke; Diet, Healthy; Muscle Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High protein diet

received high protein diet, prescribed by dietitian

Group Type: EXPERIMENTAL

high protein diet

Intervention Type: DIETARY_SUPPLEMENT

receive 1.8g protein/kg

Normal protein diet

received normal protein diet, prescribed by dietitian

Group Type: ACTIVE_COMPARATOR

normal protein diet

Intervention Type: DIETARY_SUPPLEMENT

receive 1g protein/kg

Interventions

high protein diet

receive 1.8g protein/kg

Intervention Type: DIETARY_SUPPLEMENT

normal protein diet

receive 1g protein/kg

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, , Taiwan

Countries

Taiwan

Other Identifiers

CORPG6G0191

Identifier Type: -

Identifier Source: org_study_id