Energy Dense Formula to People Living in Old Peoples Home

Anorexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259999
• Other study ID #: Huddinge Municipality and SLL
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: June 30, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Body Weight Changes
• Malnutrition
• Protein-Energy Malnutrition
• Weight Change

Intervention

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.

Locations

Country	Name	City	State
Sweden	Dep of Geriatrics, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks as intervention 6 weeks as control	No
Secondary	Increased appetite		6 weeks intervention 6 weeks control	No