Nutritional Intervention in Malnourished Elderly Patients

Phase 4TerminatedNCT00417508

University Hospital of North Norway23 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malnutrition

Interventions

Sip feedingDIETARY_SUPPLEMENT

Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)

Dietary AdviceDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Northern Norway, Dep of Medical Gastroenterology

Tromsø, Tromsoe, Norway

Outcomes

Primary Outcomes

Functional Health (Short form 36)

Time frame: Start and 12 weeks

Secondary Outcomes

Nutritional Measures (at inclusion and week 12)

Time frame: Start and 12 weeks

Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)

Time frame: at 6 and 12 weeks

Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale

Time frame: Start and 12 weeks

Observed ADL

Barthels index

Time frame: Start and at 12 weeks

Timed Up and Go test

Time frame: Start and12 weeks

Hand grip strength

Time frame: Start and 12 weeks

Data from ClinicalTrials.gov

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