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OpenTrials
Completed

NCT Number: NCT04295044

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute ischemic stroke during hospitalization
  • eGFR >30
  • urine albumin creatinine ratio < 30 mg/g
  • urinary creatinine excretion rate (CER) < 1500g/day

Exclusion criteria

  • chronic kidney disease stage 4 or 5 (i.e. eGFR < 30)
  • proteinuria (protein 1+ or more in urine routine)
  • known impairment of functional status (mRS ≥ 2) prior to the index stroke
  • refuse to participate in this study.

Treatment and study plan

high protein diet

Dietary Supplement

receive 1.8g protein/kg

normal protein diet

Dietary Supplement

receive 1g protein/kg

Primary outcomes

  1. modified Rankin Scale 0-1

    Time frame: 3 months

    No significant disability

Secondary outcomes

  1. modified Rankin Scale 0-2

    Time frame: 3 months

    Slight disability

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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