Energy Dense Oleic Acid Formula to Geriatric Patients

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01042340
First received: December 30, 2009
Last updated: January 4, 2010
Last verified: December 2009
  Purpose

Background and aims:

Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.

Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.


Condition Intervention
Nutritional Intervention
Other: Calogen® - an energy dense oleic acid based formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. [ Time Frame: 5 days to 3 weeks intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects on serum lipids and appetite [ Time Frame: 5 days to 3 weeks treatment ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention with energy dense formula
Patients were randomised to intervention with the energy dense formula Calogen.
Other: Calogen® - an energy dense oleic acid based formula
A daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00.
Other Names:
  • SHS International LTD, UK
  • Nutricia Nordica AB, Sweden
No Intervention: Control group
The patients that were randomised to control group were assigned to ordinary treatment.
Other: Calogen® - an energy dense oleic acid based formula
A daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00.
Other Names:
  • SHS International LTD, UK
  • Nutricia Nordica AB, Sweden

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria were: likely to stay at the ward more than one week, >65 years old and able to give informed consent.

Exclusion Criteria:

  • Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI >30) and non-consent for participation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042340

Locations
Sweden
Dep of Geriatrics, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
Principal Investigator: Gerd Faxén Irving, PhD Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerd Faxén Irving, Karolinska University Hosptial Huddinge and Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01042340     History of Changes
Other Study ID Numbers: Karolinska University Hospital
Study First Received: December 30, 2009
Last Updated: January 4, 2010
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Karolinska University Hospital:
nutrition
geriatric
supplement
energy

ClinicalTrials.gov processed this record on September 18, 2014