Nutritional Intervention in Malnourished Elderly Patients

Phase 4

Terminated

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Dietary Advice; Dietary Supplement: Sip feeding

• Registration Number: NCT00417508
• Lead Sponsor: University Hospital of North Norway

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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-29
• Study First Submitted QC: 2006-12-29
• Study First Posted: 2007-01-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary advice	Dietary Advice	ordinary dietary advice with a recommendation of four meals per day or similar dietary advice
Nutritional supplement	Sip feeding	2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein

Primary Outcome Measures

Name	Time	Method
Functional Health (Short form 36)	Start and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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	Barthels index
Timed Up and Go test	Start and12 weeks
Hand grip strength	Start and 12 weeks

Trial Locations

Locations (1)

University Hospital of Northern Norway, Dep of Medical Gastroenterology; 🇳🇴 Tromsoe, Norway