Nutritional Intervention in Malnourished Elderly Patients

NCT00417508 | Terminated Phase 4

• 1 other identifier: P REK NORD 64/2003
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.

Conditions

Malnutrition

Keywords

function; elderly; ADL; nutritional supplementation; Quality of life; handgrip strength; Body Composition

Outcome Measures

Primary Outcomes (1)

• Functional Health (Short form 36)

  Start and 12 weeks

Secondary Outcomes (6)

• Nutritional Measures (at inclusion and week 12)

  Start and 12 weeks

• Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)

  at 6 and 12 weeks

• Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale

  Start and 12 weeks

• Observed ADL

  Start and at 12 weeks

• Timed Up and Go test

  Start and12 weeks

Study Arms (2)

Nutritional supplement

EXPERIMENTAL

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

Dietary Supplement: Sip feeding

Dietary advice

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary Advice

Interventions

Sip feeding DIETARY_SUPPLEMENT

Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)

Also known as: Fresubin Protein Energy Drink

Nutritional supplement

Dietary Advice DIETARY_SUPPLEMENT

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.

Dietary advice

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Centre for Research in the Elderly, Tromsoe, Norway: collaborator

Study Sites (1)

University Hospital of Northern Norway, Dep of Medical Gastroenterology

Tromsø, Tromsoe, 9038, Norway

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jon R Florholmen, MD, PhD

  University Hospital of Northern Norway, Dep of Medical Gastroenterology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2006
• First Posted: January 1, 2007
• Study Start: December 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 18, 2019

Record last verified: 2012-06

Locations

NO (1)