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Effect of Intensive Nutritional Support in Subacute Stroke Patient

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Samsung Medical Center

Status

Completed

Conditions

Rehabilitation
Stroke
Nutrition

Treatments

Drug: Omapone Peri 724mL or Winuf Peri 654mL

Study type

Interventional

Funder types

Other

Identifiers

NCT04259307
2019-06-109

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

19+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

97 participants in 2 patient groups

Intensive nutrition group
Experimental group
Description:
Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks
Treatment:
Drug: Omapone Peri 724mL or Winuf Peri 654mL
Control group
No Intervention group
Description:
Standard nutritional support only per day for 3 weeks

Trial contacts and locations

1

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Central trial contact

Won Hyuk Chang, MD.,PhD.

Data sourced from clinicaltrials.gov

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