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Energy Dense Formula to People Living in Old Peoples Home

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259999
First Posted: December 15, 2010
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Karolinska Institutet
Information provided by:
Karolinska University Hospital
  Purpose
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.

Condition Intervention
Protein-Energy Malnutrition Anorexia Weight Change Dietary Supplement: Calogen extra strawberry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Increased intake of energy and nutrients [ Time Frame: 6 weeks as intervention 6 weeks as control ]
    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 [ Time Frame: 6 weeks intervention 6 weeks control ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Energy dense formula Dietary Supplement: Calogen extra strawberry
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.
Other Name: Nutricia PDS:1005912

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259999


Locations
Sweden
Dep of Geriatrics, Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
Principal Investigator: Gerd Faxen Irving, RD, PHD Karolinska University Hospital Huddinge/NVS/KI
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerd Faxén Irving, Karolinska University Hospital Huddinge and Karolinska Institutet/NVS
ClinicalTrials.gov Identifier: NCT01259999     History of Changes
Other Study ID Numbers: Huddinge Municipality and SLL
First Submitted: December 14, 2010
First Posted: December 15, 2010
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by Karolinska University Hospital:
malnutrition
oleic-acid
micronutrient supplement
old peoples home

Additional relevant MeSH terms:
Malnutrition
Anorexia
Body Weight Changes
Protein-Energy Malnutrition
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Body Weight
Protein Deficiency
Deficiency Diseases