Nutritional Intervention in Malnourished Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness of Nutritional Intervention in Malnourished Elderly Patients

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Sip feeding
* Dietary Supplement: Dietary Advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional supplement<br>2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein | Dietary Supplement: Sip feeding<br>* Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)<br>* Other names: Fresubin Protein Energy Drink;|
| Active Comparator: Dietary advice<br>ordinary dietary advice with a recommendation of four meals per day or similar dietary advice | Dietary Supplement: Dietary Advice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Health (Short form 36) |  | Start and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADL, function, elderly, nutritional supplementation, Quality of life, handgrip strength, Body Composition