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

NCT04295044 | Completed Phase 2

• 1 other identifier: CORPG6G0191
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Diet, Healthy; Muscle Loss

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale 0-1

  No significant disability

  3 months

Secondary Outcomes (1)

• modified Rankin Scale 0-2

  3 months

Study Arms (2)

High protein diet

EXPERIMENTAL

received high protein diet, prescribed by dietitian

Dietary Supplement: high protein diet

Normal protein diet

ACTIVE COMPARATOR

received normal protein diet, prescribed by dietitian

Dietary Supplement: normal protein diet

Interventions

high protein diet DIETARY_SUPPLEMENT

receive 1.8g protein/kg

High protein diet

normal protein diet DIETARY_SUPPLEMENT

receive 1g protein/kg

Normal protein diet

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, 613, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke; Muscular Atrophy

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 4, 2020
• Study Start: December 15, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)