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

Primary Purpose

Ischemic Stroke, Diet, Healthy, Muscle Loss

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
high protein diet
normal protein diet
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chang Gung Memorial Hospital, Chiayi Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High protein diet

Normal protein diet

Arm Description

received high protein diet, prescribed by dietitian

received normal protein diet, prescribed by dietitian

Outcomes

Primary Outcome Measures

modified Rankin Scale 0-1
No significant disability

Secondary Outcome Measures

modified Rankin Scale 0-2
Slight disability

Full Information

First Posted
March 3, 2020
Last Updated
March 28, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04295044
Brief Title
Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
Official Title
Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Diet, Healthy, Muscle Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High protein diet
Arm Type
Experimental
Arm Description
received high protein diet, prescribed by dietitian
Arm Title
Normal protein diet
Arm Type
Active Comparator
Arm Description
received normal protein diet, prescribed by dietitian
Intervention Type
Dietary Supplement
Intervention Name(s)
high protein diet
Intervention Description
receive 1.8g protein/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
normal protein diet
Intervention Description
receive 1g protein/kg
Primary Outcome Measure Information:
Title
modified Rankin Scale 0-1
Description
No significant disability
Time Frame
3 months
Secondary Outcome Measure Information:
Title
modified Rankin Scale 0-2
Description
Slight disability
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Chiayi Branch
City
Chiayi City
ZIP/Postal Code
613
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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