---
title: Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
nct_id: NCT04295044
overall_status: COMPLETED
phase: PHASE2
sponsor: Chang Gung Memorial Hospital
study_type: INTERVENTIONAL
primary_condition: Ischemic Stroke
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04295044.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04295044"
ct_last_update_post_date: 2023-03-30
last_seen_at: "2026-05-12T07:22:21.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of High Protein Diet in Stroke Patients With Low Muscle Mass

**NCT ID:** [NCT04295044](https://clinicaltrials.gov/study/NCT04295044)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Chang Gung Memorial Hospital
- **Conditions:** Ischemic Stroke, Diet, Healthy, Muscle Loss
- **Start Date:** 2017-12-15
- **Completion Date:** 2021-03-31
- **CT.gov Last Update:** 2023-03-30

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **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.
```

## Arms

- **High protein diet** (EXPERIMENTAL) — received high protein diet, prescribed by dietitian
- **Normal protein diet** (ACTIVE_COMPARATOR) — received normal protein diet, prescribed by dietitian

## Interventions

- **high protein diet** (DIETARY_SUPPLEMENT) — receive 1.8g protein/kg
- **normal protein diet** (DIETARY_SUPPLEMENT) — receive 1g protein/kg

## Primary Outcomes

- **modified Rankin Scale 0-1** _(time frame: 3 months)_ — No significant disability

## Secondary Outcomes

- **modified Rankin Scale 0-2** _(time frame: 3 months)_

## Locations (1)

- Chang Gung Memorial Hospital, Chiayi Branch, Chiayi City, Taiwan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chang gung memorial hospital, chiayi branch|chiayi city||taiwan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04295044.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04295044*  
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