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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke; Muscle Loss; Diet, Healthy

Treatments: Dietary Supplement: normal protein diet; Dietary Supplement: high protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04295044

CORPG6G0191

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

High protein diet

Experimental group

Description:

received high protein diet, prescribed by dietitian

Treatment:

Dietary Supplement: high protein diet

Normal protein diet

Active Comparator group

Description:

received normal protein diet, prescribed by dietitian

Treatment:

Dietary Supplement: normal protein diet