Clinical trial NCT01259999: 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
Overall status: COMPLETED
Phase: NA
Conditions: Protein-Energy Malnutrition
Anorexia
Weight Change
Keywords: malnutrition
oleic-acid
micronutrient supplement
old peoples home
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2010-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Increased intake of energy and nutrients
timeFrame: 6 weeks as intervention 6 weeks as control
Secondary outcomes:
measure: Increased appetite
timeFrame: 6 weeks intervention 6 weeks control
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dep of Geriatrics, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital Huddinge/NVS/KI
name: Gerd Faxen Irving, RD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.