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Clinical Trials/NCT00417508
NCT00417508
Terminated
Phase 4

Effectiveness of Nutritional Intervention in Malnourished Elderly Patients

University Hospital of North Norway1 site in 1 country23 target enrollmentDecember 2006
ConditionsMalnutrition

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Malnutrition
Sponsor
University Hospital of North Norway
Enrollment
23
Locations
1
Primary Endpoint
Functional Health (Short form 36)
Status
Terminated
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
May 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional Health (Short form 36)

Time Frame: Start and 12 weeks

Secondary Outcomes

  • 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(Start and at 12 weeks)
  • Timed Up and Go test(Start and12 weeks)
  • Hand grip strength(Start and 12 weeks)

Study Sites (1)

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