Nutritional Intervention in Malnourished Elderly Patients
This study has been completed.
Sponsor:
University Hospital of North Norway
Collaborator:
Centre for Research in the Elderly, Tromsoe, Norway
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00417508
First received: December 29, 2006
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition |
Dietary Supplement: Sip feeding Dietary Supplement: Dietary Advice |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness of Nutritional Intervention in Malnourished Elderly Patients |
Resource links provided by NLM:
Further study details as provided by University Hospital of North Norway:
Primary Outcome Measures:
- Functional Health (Short form 36) [ Time Frame: Start and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Nutritional Measures (at inclusion and week 12) [ Time Frame: Start and 12 weeks ] [ Designated as safety issue: No ]
- Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry) [ Time Frame: at 6 and 12 weeks ] [ Designated as safety issue: No ]
- Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale [ Time Frame: Start and 12 weeks ] [ Designated as safety issue: No ]
- Observed ADL [ Time Frame: Start and at 12 weeks ] [ Designated as safety issue: No ]Barthels index
- Timed Up and Go test [ Time Frame: Start and12 weeks ] [ Designated as safety issue: No ]
- Hand grip strength [ Time Frame: Start and 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | December 2006 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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.
|
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
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417508
Locations
| Norway | |
| University Hospital of Northern Norway, Dep of Medical Gastroenterology | |
| Tromsoe, Norway, 9038 | |
Sponsors and Collaborators
University Hospital of North Norway
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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT00417508 History of Changes |
| Other Study ID Numbers: | P REK NORD 64/2003 |
| Study First Received: | December 29, 2006 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by University Hospital of North Norway:
|
function elderly ADL nutritional supplementation |
Quality of life handgrip strength Body Composition |
Additional relevant MeSH terms:
|
Food Habits Malnutrition Habits Nutrition Disorders |
ClinicalTrials.gov processed this record on May 22, 2013