A Phase 2/3 interventional study of high protein supplement in Stroke and Malnutrition, sponsored by Seoul National University Bundang Hospital. Terminated at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2015-07-02.
Sponsored by Seoul National University Bundang Hospital · Phase 2/3, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
high protein supplement given
Dietary Supplement: high protein supplement
no intervention
Dietary Supplement: high protein supplement
Also known as: Intensive Nutritional Supplement group
Modified Barthel Index (MBI) Score at 6 Months
Scale range: 0-100 (higher values represent a better outcome)
Time frame: 6 months
Chemical Laboratory Findings
Time frame: 6 months
Body Mass Index
Time frame: 6 months
Triceps Skin Fold Thickness
Time frame: 6 months
Subjective Global Assessment
Time frame: 6 months
* first ever stroke * MRI confirms his/her stroke * weight loss over 2.5% within 2 weeks after the stroke onset * MMSE \>= 10 * medically stable
| Milestone | High Protein Supplement | Control |
|---|---|---|
| Started | 16 | 18 |
| Completed | 8 | 11 |
| Not completed | 8 | 7 |
| Withdrew: Lost to follow-up | 8 | 7 |
Scale range: 0-100 (higher values represent a better outcome)
| units on a scale | High Protein Supplement | Control |
|---|---|---|
| Modified Barthel Index (MBI) Score at 6 Months | 23.3 ± 2.7 | 21.9 ± 2.7 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Protein Supplement | — | 0/16 (0%) | 0/16 (0%) |
| Control | — | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | High Protein Supplement | Control | Total |
|---|---|---|---|
| Mean | 62.8 ± 16.0 | 65.8 ± 14.3 | 64.4 ± 15.2 |
| Sex: Female, Male(Participants) | High Protein Supplement | Control | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 7 | 11 | 18 |
| Region of Enrollment(participants) | High Protein Supplement | Control | Total |
|---|---|---|---|
| Korea, Republic of | 16 | 18 | 34 |
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital