Energy Dense Oleic Acid Formula to Geriatric 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. Identifier: NCT01042340
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : April 1, 2015
Karolinska Institutet
Information provided by:
Karolinska University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Nutritional Intervention Other: Calogen® - an energy dense oleic acid based formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
Study Start Date : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Effects on serum lipids and appetite [ Time Frame: 5 days to 3 weeks treatment ]

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01042340

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gerd Faxén Irving, Karolinska University Hosptial Huddinge and Karolinska Institutet Identifier: NCT01042340     History of Changes
Other Study ID Numbers: Karolinska University Hospital
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: December 2009

Keywords provided by Karolinska University Hospital: