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
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
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
NCT ID
NCT00417508
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
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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Nutritional Intervention in Malnourished Elderly Patients
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