Malnutrition
Conditions
Keywords
function, elderly, ADL, nutritional supplementation, Quality of life, handgrip strength, Body Composition
Brief summary
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTSip feeding
Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
DIETARY_SUPPLEMENTDietary Advice
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.
Sponsors
Centre for Research in the Elderly, Tromsoe, Norway
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body Mass Index \< 20 kg/m2 * Medical In/Outpatient or District Nurse-patient * Able to take nutritional supplement (sip feeding) * Able to walk * Written patient informed consent
Exclusion criteria
* Actual malignancy * Dementia with a Mini Mental Status score \< 24 * Severe depression * Need for Total Parenteral Nutrition or Tube Feeding * Prescribed nutritional supplements during more than the last week * Life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Health (Short form 36) | Start and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry) | at 6 and 12 weeks | — |
| Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale | Start and 12 weeks | — |
| Nutritional Measures (at inclusion and week 12) | Start and 12 weeks | — |
| Timed Up and Go test | Start and12 weeks | — |
| Hand grip strength | Start and 12 weeks | — |
| Observed ADL | Start and at 12 weeks | Barthels index |
Countries
Norway
Outcome results
None listed