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

NCT04295044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-03-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

high protein diet

receive 1.8g protein/kg

DIETARY_SUPPLEMENT

normal protein diet

receive 1g protein/kg

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295044 on ClinicalTrials.gov