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Nutritional Intervention in Malnourished Elderly Patients

Primary Purpose

Malnutrition

Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Sip feeding
Dietary Advice
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring function, elderly, ADL, nutritional supplementation, Quality of life, handgrip strength, Body Composition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of Northern Norway, Dep of Medical Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutritional supplement

Dietary advice

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional Health (Short form 36)

Secondary Outcome Measures

Nutritional Measures (at inclusion and week 12)
Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
Observed ADL
Barthels index
Timed Up and Go test
Hand grip strength

Full Information

First Posted
December 29, 2006
Last Updated
April 16, 2019
Sponsor
University Hospital of North Norway
Collaborators
Centre for Research in the Elderly, Tromsoe, Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00417508
Brief Title
Nutritional Intervention in Malnourished Elderly Patients
Official Title
Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
It was not possible to recruite sufficient number of participants
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Centre for Research in the Elderly, Tromsoe, Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
function, elderly, ADL, nutritional supplementation, Quality of life, handgrip strength, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional supplement
Arm Type
Experimental
Arm Description
2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein
Arm Title
Dietary advice
Arm Type
Active Comparator
Arm Description
ordinary dietary advice with a recommendation of four meals per day or similar dietary advice
Intervention Type
Dietary Supplement
Intervention Name(s)
Sip feeding
Other Intervention Name(s)
Fresubin Protein Energy Drink
Intervention Description
Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Health (Short form 36)
Time Frame
Start and 12 weeks
Secondary Outcome Measure Information:
Title
Nutritional Measures (at inclusion and week 12)
Time Frame
Start and 12 weeks
Title
Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
Time Frame
at 6 and 12 weeks
Title
Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
Time Frame
Start and 12 weeks
Title
Observed ADL
Description
Barthels index
Time Frame
Start and at 12 weeks
Title
Timed Up and Go test
Time Frame
Start and12 weeks
Title
Hand grip strength
Time Frame
Start and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon R Florholmen, MD, PhD
Organizational Affiliation
University Hospital of Northern Norway, Dep of Medical Gastroenterology
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Northern Norway, Dep of Medical Gastroenterology
City
Tromsoe
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

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