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Energy Dense Formula to People Living in Old Peoples Home

Primary Purpose

Protein-Energy Malnutrition, Anorexia, Weight Change

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Calogen extra strawberry
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-Energy Malnutrition focused on measuring malnutrition, oleic-acid, micronutrient supplement, old peoples home

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >65 years old
  • Mini nutritional assessment-short form (MNA-SF)score < 12 points
  • able to give informed consent.

Exclusion Criteria:

  • pancreatitis
  • fat malabsorption, non-consent for participation.
  • Subjects that have Calogen will be excluded.

Sites / Locations

  • Dep of Geriatrics, Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Energy dense formula

Arm Description

Outcomes

Primary Outcome Measures

Increased intake of energy and nutrients
The sample size has been estimated upon a minimum difference in daily energy intake between the Control and Calogen group of 200 kcal (4). To detect a significant difference in energy intake at the 5% significance level and with 80% power 27 subjects in each group were needed. To allow for study drop-outs this is increased to 30 subjects in each group.

Secondary Outcome Measures

Increased appetite

Full Information

First Posted
December 14, 2010
Last Updated
June 30, 2011
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01259999
Brief Title
Energy Dense Formula to People Living in Old Peoples Home
Official Title
Distribution of an Energy Rich Formula at Medication Rounds to Individuals Living in Old Peoples Home - Effects on Energy Intake Compared to Standard Nutritional Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dietary intake in frail elderly is often lower than estimated needs due to the combined effects of the anorexia of ageing, frailty and the presence of acute and chronic disease. The objectives of the present study are to assess the effects of an oleic acid rich formula fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength and mobility. The investigators have recently performed a similar study in an acute ward setting without micronutrients.
Detailed Description
Malnutrition has been reported to be present in up to 55% of acutely hospitalised elderly and in one third of people living in assisted accommodation. Frail elderly with poor appetite are at risk for malnutrition. Rebecca Stratton et al have reviewed effects of oral nutritional supplements (ONS) in elderly hospital patients and key findings in hospital trials were that ONS can improve intakes of energy, protein and micronutrients without substantially reducing food intake which may lead to weight gain or attenuate weight loss. Calogen extra is a fat emulsion containing 400 kcal/100 ml, based on canola and sunflower-oil which has a good fat composition. Moreover it contains around 30 % of recommended micronutrients and 5g protein/100 ml. It has potentially positive effects on energy intake, fatty acid profile and constipation. The investigators have recently performed a clinical trial in geriatric patients in an acute-ward setting to evaluate the effects of a similar fat emulsion, Calogen, without micronutrients. The investigators could conclude that this fat emulsion based on MUFA and PUFA distributed three times daily at medication rounds may have positive effects on weight, appetite and serum lipids. Moreover the approach was well accepted by patients and nurses. The intervention period was very short (median 8 days) therefore the investigators plan to perform a study with a similar design, for a longer period of time, in a group of elderly living in old peoples home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Energy Malnutrition, Anorexia, Weight Change
Keywords
malnutrition, oleic-acid, micronutrient supplement, old peoples home

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy dense formula
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Calogen extra strawberry
Other Intervention Name(s)
Nutricia PDS:1005912
Intervention Description
A daily dose of 3 x 30 ml Calogen extra strawberry flavour will be distributed at the same time as the medicines i.e. at 8.00, 12.00 and 20.00.
Primary Outcome Measure Information:
Title
Increased intake of energy and nutrients
Description
The sample size has been estimated upon a minimum difference in daily energy intake between the Control and Calogen group of 200 kcal (4). To detect a significant difference in energy intake at the 5% significance level and with 80% power 27 subjects in each group were needed. To allow for study drop-outs this is increased to 30 subjects in each group.
Time Frame
6 weeks as intervention 6 weeks as control
Secondary Outcome Measure Information:
Title
Increased appetite
Time Frame
6 weeks intervention 6 weeks control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >65 years old Mini nutritional assessment-short form (MNA-SF)score < 12 points able to give informed consent. Exclusion Criteria: pancreatitis fat malabsorption, non-consent for participation. Subjects that have Calogen will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Faxen Irving, RD, PHD
Organizational Affiliation
Karolinska University Hospital Huddinge/NVS/KI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep of Geriatrics, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26810442
Citation
Tylner S, Cederholm T, Faxen-Irving G. Effects on Weight, Blood Lipids, Serum Fatty Acid Profile and Coagulation by an Energy-Dense Formula to Older Care Residents: A Randomized Controlled Crossover Trial. J Am Med Dir Assoc. 2016 Mar 1;17(3):275.e5-11. doi: 10.1016/j.jamda.2015.12.005. Epub 2016 Jan 23.
Results Reference
derived

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Energy Dense Formula to People Living in Old Peoples Home

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