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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01042340
Other study ID # Karolinska University Hospital
Secondary ID
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


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
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