Nutritional Intervention in Malnourished Elderly Patients

Malnutrition Clinical Trial

Official title:

Effectiveness of Nutritional Intervention in Malnourished Elderly Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00417508
• Other study ID #: P REK NORD 64/2003
• Status: Terminated
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Sip feeding
Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
• Dietary 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.

Locations

Country	Name	City	State
Norway	University Hospital of Northern Norway, Dep of Medical Gastroenterology	Tromsoe

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Centre for Research in the Elderly, Tromsoe, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Health (Short form 36)		Start and 12 weeks
Secondary	Nutritional Measures (at inclusion and week 12)		Start and 12 weeks
Secondary	Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)		at 6 and 12 weeks
Secondary	Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale		Start and 12 weeks
Secondary	Observed ADL	Barthels index	Start and at 12 weeks
Secondary	Timed Up and Go test		Start and12 weeks
Secondary	Hand grip strength		Start and 12 weeks