NCT01810263

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 2, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

February 1, 2013

Results QC Date

May 18, 2015

Last Update Submit

July 1, 2015

Conditions

StrokeMalnutrition

Keywords

strokemalnutritionhigh protein

Outcome Measures

Primary Outcomes (1)

  • Modified Barthel Index (MBI) Score at 6 Months

    Scale range: 0-100 (higher values represent a better outcome)

    6 months

Secondary Outcomes (1)

  • Chemical Laboratory Findings

    6 months

Other Outcomes (3)

  • Body Mass Index

    6 months

  • Triceps Skin Fold Thickness

    6 months

  • Subjective Global Assessment

    6 months

Study Arms (2)

high protein supplement

EXPERIMENTAL

high protein supplement given

Dietary Supplement: high protein supplement

Control

NO INTERVENTION

no intervention

Interventions

high protein supplementDIETARY_SUPPLEMENT

Dietary Supplement: high protein supplement

Also known as: Intensive Nutritional Supplement group
high protein supplement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • recurrent stroke patient
  • malabsorption patient
  • terminal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 9771334BACKGROUND

  • 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.

    PMID: 3239449BACKGROUND

  • Sakai K, Niimi M, Momosaki R, Hoshino E, Yoneoka D, Nakayama E, Masuoka K, Maeda T, Takahashi N, Sakata N. Nutritional therapy for reducing disability and improving activities of daily living in people after stroke. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD014852. doi: 10.1002/14651858.CD014852.pub2.

    PMID: 39145517DERIVED

MeSH Terms

Conditions

StrokeMalnutrition

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Nam-Jong Paik
Organization
Seoul National University Bundang Hospital
njpaik@snu.ac.kr
82-031-787-7731

Study Officials

  • Nam-Jong Paik, MD, PhD

    Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 1, 2013

First Posted

March 13, 2013

Study Start

May 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 2, 2015

Results First Posted

July 2, 2015

Record last verified: 2015-07

Locations

KR(1)