Nutritional Intervention in Malnourished Elderly Patients

University Hospital of North Norway

Status and phase: Terminated; Phase 4

Conditions: Malnutrition

Treatments: Dietary Supplement: Dietary Advice; Dietary Supplement: Sip feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT00417508

P REK NORD 64/2003

Details and patient eligibility

About

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

Full 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

Enrollment: 23 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Nutritional supplement

Experimental group

Description:

2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein

Treatment:

Dietary Supplement: Sip feeding

Dietary advice

Active Comparator group

Description:

ordinary dietary advice with a recommendation of four meals per day or similar dietary advice

Treatment:

Dietary Supplement: Dietary Advice