We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Intervention in Malnourished Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00417508
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Sip feeding Dietary Supplement: Dietary Advice Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
Study Start Date : December 2006
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. Functional Health (Short form 36) [ Time Frame: Start and 12 weeks ]

Secondary Outcome Measures :
  1. Nutritional Measures (at inclusion and week 12) [ Time Frame: Start and 12 weeks ]
  2. Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry) [ Time Frame: at 6 and 12 weeks ]
  3. Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale [ Time Frame: Start and 12 weeks ]
  4. Observed ADL [ Time Frame: Start and at 12 weeks ]
    Barthels index

  5. Timed Up and Go test [ Time Frame: Start and12 weeks ]
  6. Hand grip strength [ Time Frame: Start and 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00417508     History of Changes
Other Study ID Numbers: P REK NORD 64/2003
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by University Hospital of North Norway:
function
elderly
ADL
nutritional supplementation
Quality of life
handgrip strength
Body Composition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders