The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stroke Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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high protein supplement

high protein supplement given

Group Type EXPERIMENTAL

high protein supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: high protein supplement

Control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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high protein supplement

Dietary Supplement: high protein supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Intensive Nutritional Supplement group

Eligibility Criteria

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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