Energy Dense Oleic Acid Formula to Geriatric Patients

Not Applicable

Completed

• Conditions: Nutritional Intervention
• Interventions: Other: Calogen® - an energy dense oleic acid based formula

• Registration Number: NCT01042340
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2009-12
• Study First Submitted: 2009-12-30
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with energy dense formula	Calogen® - an energy dense oleic acid based formula	Patients were randomised to intervention with the energy dense formula Calogen.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Effects on serum lipids and appetite	5 days to 3 weeks treatment

Trial Locations

Locations (1)

Dep of Geriatrics, Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden