Nutritional Intervention in Malnourished Elderly Patients

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 22, 2014