Stroke, Malnutrition
Conditions
Keywords
stroke, malnutrition, high protein
Brief summary
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
Detailed 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.
Interventions
DIETARY_SUPPLEMENThigh protein supplement
Dietary Supplement: high protein supplement
Sponsors
Myongji Hospital
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Barthel Index (MBI) Score at 6 Months | 6 months | Scale range: 0-100 (higher values represent a better outcome) |
Secondary
| Measure | Time frame |
|---|---|
| Chemical Laboratory Findings | 6 months |
Other
| Measure | Time frame |
|---|---|
| Body Mass Index | 6 months |
| Triceps Skin Fold Thickness | 6 months |
| Subjective Global Assessment | 6 months |
Countries
South Korea
Participant flow
Recruitment details
* first ever stroke * MRI confirms his/her stroke * weight loss over 2.5% within 2 weeks after the stroke onset * MMSE \>= 10 * medically stable
Participants by arm
| Arm | Count |
|---|---|
| High Protein Supplement high protein supplement given | 16 |
| Control no intervention | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 7 |
Baseline characteristics
| Characteristic | High Protein Supplement | Control | Total |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 16 | 65.8 years STANDARD_DEVIATION 14.3 | 64.4 years STANDARD_DEVIATION 15.2 |
| Region of Enrollment Korea, Republic of | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
Primary
Modified Barthel Index (MBI) Score at 6 Months
Scale range: 0-100 (higher values represent a better outcome)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Protein Supplement | Modified Barthel Index (MBI) Score at 6 Months | 23.3 units on a scale | Standard Deviation 2.7 |
| Control | Modified Barthel Index (MBI) Score at 6 Months | 21.9 units on a scale | Standard Deviation 2.7 |
Secondary
Chemical Laboratory Findings
Time frame: 6 months
Other Pre-specified
Body Mass Index
Time frame: 6 months
Other Pre-specified
Subjective Global Assessment
Time frame: 6 months
Other Pre-specified
Triceps Skin Fold Thickness
Time frame: 6 months