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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295044
• Other study ID #: CORPG6G0191
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Healthy
• Ischemic Stroke
• Muscle Loss
• Stroke

Intervention

Dietary Supplement:
• high protein diet
receive 1.8g protein/kg
• normal protein diet
receive 1g protein/kg

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Chiayi Branch	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale 0-1	No significant disability	3 months
Secondary	modified Rankin Scale 0-2	Slight disability	3 months