Energy Dense Oleic Acid Formula to Geriatric Patients
Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 30, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedApril 1, 2015
December 1, 2009
1.5 years
December 30, 2009
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power.
5 days to 3 weeks intervention
Secondary Outcomes (1)
Effects on serum lipids and appetite
5 days to 3 weeks treatment
Study Arms (2)
Intervention with energy dense formula
EXPERIMENTALPatients were randomised to intervention with the energy dense formula Calogen.
Control group
NO INTERVENTIONThe patients that were randomised to control group were assigned to ordinary treatment.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Karolinska Institutetcollaborator
Study Sites (1)
Dep of Geriatrics, Karolinska University Hospital, Huddinge
Stockholm, 141 86, Sweden
Related Publications (2)
Milne AC, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003288. doi: 10.1002/14651858.CD003288.pub2.
PMID: 15846655BACKGROUNDFaxen-Irving G, Cederholm T. Energy dense oleic acid rich formula to newly admitted geriatric patients--feasibility and effects on energy intake. Clin Nutr. 2011 Apr;30(2):202-8. doi: 10.1016/j.clnu.2010.08.007. Epub 2010 Sep 19.
PMID: 20855136DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gerd Faxén Irving, PhD
Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 30, 2009
First Posted
January 5, 2010
Study Start
December 1, 2005
Primary Completion
June 1, 2007
Study Completion
July 1, 2007
Last Updated
April 1, 2015
Record last verified: 2009-12