The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Seoul National University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Malnutrition; Stroke

Treatments: Dietary Supplement: high protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01810263

B-1112-069-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

high protein supplement

Experimental group

Description:

high protein supplement given

Treatment:

Dietary Supplement: high protein supplement

Control

No Intervention group

Description:

no intervention