Effect of Intensive Nutritional Support in Subacute Stroke Patient

Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04259307

Enrollment

Registered

2020-02-06

Start date

2020-01-29

Completion date

2023-12-31

Last updated

2024-03-07

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

Conditions

Nutrition, Rehabilitation, Stroke

Brief summary

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

Interventions

DRUGOmapone Peri 724mL or Winuf Peri 654mL

Additional intravenous nutrition of 500 kcal per day for 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Acute first-ever stroke patients less than 7 days after onset * more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI * body mass index (BMI) \<25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment \< 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment \< 85 at 7 days after stroke onset

Exclusion criteria

* Transient ischemic stroke * Progressive or unstable stroke * Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al. * Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.) * A terminal medical diagnosis consistent with survival \< 1 year * Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Design outcomes

Primary

Measure	Time frame	Description
Korean modified Barthel Index (K-MBI) at 6 months after onset	6 months after onset	Korean modified Barthel Index (0\ 100)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026