The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Phase 2

Terminated

• Conditions: Stroke; Malnutrition
• Interventions: Dietary Supplement: high protein supplement

• Registration Number: NCT01810263
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-05-18
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-01
• Last Update Submitted: 2015-07-01
• Results First Posted: 2015-07-02
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

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Exclusion Criteria

• recurrent stroke patient
• malabsorption patient
• terminal cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high protein supplement	high protein supplement	high protein supplement given

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Chemical Laboratory Findings	6 months

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of