Nutritional Intervention in Malnourished Elderly Patients

April 16, 2019 updated by: University Hospital of North Norway

Effectiveness of Nutritional Intervention in Malnourished Elderly Patients

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsoe, Norway, 9038
        • University Hospital of Northern Norway, Dep of Medical Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional supplement
2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein
Dietary supplement: Sip feeding
Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
Other Names:
  • Fresubin Protein Energy Drink
Active Comparator: Dietary advice
ordinary dietary advice with a recommendation of four meals per day or similar dietary advice
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Health (Short form 36)
Time Frame: Start and 12 weeks
Start and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional Measures (at inclusion and week 12)
Time Frame: Start and 12 weeks
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
at 6 and 12 weeks
Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
Time Frame: Start and 12 weeks
Start and 12 weeks
Observed ADL
Time Frame: Start and at 12 weeks
Barthels index
Start and at 12 weeks
Timed Up and Go test
Time Frame: Start and12 weeks
Start and12 weeks
Hand grip strength
Time Frame: Start and 12 weeks
Start and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Centre for Research in the Elderly, Tromsoe, Norway

Investigators

  • Study Chair: Jon R Florholmen, MD, PhD, University Hospital of Northern Norway, Dep of Medical Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 29, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (Estimate)

January 1, 2007

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P REK NORD 64/2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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