Energy Dense Oleic Acid Formula to Geriatric Patients

March 31, 2015 updated by: Karolinska University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Dep of Geriatrics, Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention with energy dense formula
Patients were randomised to intervention with the energy dense formula Calogen.
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.
Other Names:
  • SHS International LTD, UK
  • Nutricia Nordica AB, Sweden
No Intervention: Control group
The patients that were randomised to control group were assigned to ordinary treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 days to 3 weeks intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects on serum lipids and appetite
Time Frame: 5 days to 3 weeks treatment
5 days to 3 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Gerd Faxén Irving, PhD, Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Karolinska University Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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