The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Overview

The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Full Title of Study: “The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2014

Detailed Description

Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Interventions

  • Dietary Supplement: high protein supplement
    • Dietary Supplement: high protein supplement

Arms, Groups and Cohorts

  • Experimental: high protein supplement
    • high protein supplement given
  • No Intervention: Control
    • no intervention

Clinical Trial Outcome Measures

Primary Measures

  • Modified Barthel Index (MBI) Score at 6 Months
    • Time Frame: 6 months
    • Scale range: 0-100 (higher values represent a better outcome)

Secondary Measures

  • Chemical Laboratory Findings
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • 1 st onset stroke patient – MRI confirms his/her stroke – more than 2.5% weight los within 2 weeks – initial serum albumin < 35 g/l – BMI < 18.5 – more than MMSE 10 – medically stable Exclusion Criteria:

  • recurrent stroke patient – malabsorption patient – terminal cancer

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Collaborator
    • Myongji Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nam-Jong Paik, professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Nam-Jong Paik, MD, PhD, Principal Investigator, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

References

Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. doi: 10.1079/bjn19980085.

Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. doi: 10.1111/j.0954-6820.1988.tb19364.x.

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