Energy Dense Oleic Acid Formula to Geriatric Patients

Nutritional Intervention Clinical Trial

Official title:

Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042340
• Other study ID #: Karolinska University Hospital
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: March 31, 2015
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2009
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nutritional Intervention

Intervention

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.

Locations

Country	Name	City	State
Sweden	Dep of Geriatrics, Karolinska University Hospital, Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD003288. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Effects on serum lipids and appetite		5 days to 3 weeks treatment	Yes