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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04295044
Enrollment
110
Registered
2020-03-04
Start date
2017-12-15
Completion date
2021-03-31
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Diet, Healthy, Muscle Loss

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.

Interventions

DIETARY_SUPPLEMENThigh protein diet

receive 1.8g protein/kg

DIETARY_SUPPLEMENTnormal protein diet

receive 1g protein/kg

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
modified Rankin Scale 0-13 monthsNo significant disability

Secondary

MeasureTime frameDescription
modified Rankin Scale 0-23 monthsSlight disability

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026