Energy Dense Oleic Acid Formula to Geriatric Patients
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|ClinicalTrials.gov Identifier: NCT01042340|
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : April 1, 2015
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
No Intervention: Control group
The patients that were randomised to control group were assigned to ordinary treatment.
- 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 ]
- Effects on serum lipids and appetite [ Time Frame: 5 days to 3 weeks treatment ]
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): NCT01042340
|Dep of Geriatrics, Karolinska University Hospital, Huddinge|
|Stockholm, Sweden, 141 86|
|Principal Investigator:||Gerd Faxén Irving, PhD||Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute|