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Completed

NCT Number: NCT01042340

Energy Dense Oleic Acid Formula to Geriatric Patients

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.

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Key information

Conditions

Nutritional Intervention

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep of Geriatrics, Karolinska University Hospital, Huddinge

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calogen® - an energy dense oleic acid based formula

Other

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.

Other names: SHS International LTD, UK, Nutricia Nordica AB, Sweden

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.

    Time frame: 5 days to 3 weeks intervention

Secondary outcomes

  1. Effects on serum lipids and appetite

    Time frame: 5 days to 3 weeks treatment

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 5, 2010
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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