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The study does not seem to provide benefits to patients.
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| Name | Class |
|---|---|
| Myongji Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high protein supplement | Experimental | high protein supplement given |
|
| Control | No Intervention | no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high protein supplement | Dietary Supplement | Dietary Supplement: high protein supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Barthel Index (MBI) Score at 6 Months | Scale range: 0-100 (higher values represent a better outcome) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chemical Laboratory Findings | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | 6 months | |
| Triceps Skin Fold Thickness | 6 months | |
| Subjective Global Assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, MD, PhD | Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Korea, Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9771334 | Background | 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. | |
| 3239449 | Background | 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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| ID | Title | Description |
|---|---|---|
| FG000 | High Protein Supplement | Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day. (As a result, additional calories are 600kcal a day) |
| FG001 | Control | Patients in the both groups keep on routine diet in the hospital. No additional calories are provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Protein Supplement | high protein supplement given |
| BG001 | Control | no intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Barthel Index (MBI) Score at 6 Months | Scale range: 0-100 (higher values represent a better outcome) | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
3 months
Serious and other non-serious adverse events were not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Protein Supplement | high protein supplement given |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nam-Jong Paik | Seoul National University Bundang Hospital | 82-031-787-7731 | njpaik@snu.ac.kr |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6 months |
| 39145517 | Derived | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Chemical Laboratory Findings | Not Posted | 6 months |
| Other Pre-specified | Body Mass Index | Not Posted | 6 months |
| Other Pre-specified | Triceps Skin Fold Thickness | Not Posted | 6 months |
| Other Pre-specified | Subjective Global Assessment | Not Posted | 6 months |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control | no intervention | 0 | 18 | 0 | 18 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |