Energy Dense Formula to People Living in Old Peoples Home
|ClinicalTrials.gov Identifier: NCT01259999|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Protein-Energy Malnutrition Anorexia Weight Change||Dietary Supplement: Calogen extra strawberry||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||May 2011|
|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
- 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.
- Increased appetite [ Time Frame: 6 weeks intervention 6 weeks control ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259999
|Dep of Geriatrics, Karolinska University Hospital|
|Stockholm, Sweden, 141 86|
|Principal Investigator:||Gerd Faxen Irving, RD, PHD||Karolinska University Hospital Huddinge/NVS/KI|