Energy Dense Formula to People Living in Old Peoples Home

Not Applicable

Completed

• Conditions: Protein-Energy Malnutrition; Anorexia; Weight Change
• Interventions: Dietary Supplement: Calogen extra strawberry

• Registration Number: NCT01259999
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Energy dense formula	Calogen extra strawberry	-

Primary Outcome Measures

Name	Time	Method
Increased intake of energy and nutrients	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

Name	Time	Method
Increased appetite	6 weeks intervention 6 weeks control

Trial Locations

Locations (1)

Dep of Geriatrics, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden