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It was not possible to recruite sufficient number of participants
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| Name | Class |
|---|---|
| Centre for Research in the Elderly, Tromsoe, Norway | UNKNOWN |
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The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index < 20 kg/m2 are asked to participate.
Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.
Primary and secondary outcome parameters are measured at inclusion and week 12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplement | Experimental | 2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein |
|
| Dietary advice | Active Comparator | ordinary dietary advice with a recommendation of four meals per day or similar dietary advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sip feeding | Dietary Supplement | Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Health (Short form 36) | Start and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Measures (at inclusion and week 12) | Start and 12 weeks | |
| Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry) | at 6 and 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon R Florholmen, MD, PhD | University Hospital of Northern Norway, Dep of Medical Gastroenterology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Northern Norway, Dep of Medical Gastroenterology | Tromsø | Tromsoe | 9038 | Norway |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Dietary Advice | Dietary Supplement | The patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements. |
|
| Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale |
| Start and 12 weeks |
| Observed ADL | Barthels index | Start and at 12 weeks |
| Timed Up and Go test | Start and12 weeks |
| Hand grip strength | Start and 12 weeks |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |