Malnutrition
Conditions
Keywords
Malnutrition
Brief summary
Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.
Detailed description
Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome. Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community. The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements. The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.
Interventions
DIETARY_SUPPLEMENTE+
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipients of homecare services in the municipality of Bergen * Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment) * Informed consent by participant * Informed consent by participants and close relatives or guardian in case of dementia
Exclusion criteria
* Terminal care patients with \< 3 month life expectancy * Patients using parenteral or enteral nutrition * Patients prescribed oral nutritional supplementation before recruitment * Pregnancy * Diabetes Mellitus * Lactose intolerance * Patients without a norwegian personal identification number * Psychiatric patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hand grip strength | Assessment at day 0, 35 and 70. | Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial. |
| Change in Body weight | At day 0, 35 and 70 | Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales. |
| Change in Body composition | At day 0, 35 and 70 | A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nutritional intake | At day 0, 35 and 70 | Dietary intake will be assessed for each study participant using a twenty-four-hour recall method conducted by the investigator and two additional people employed to help with the data collection. All three data collectors will use a standardized interview. The data collected will be used to calculate daily calorie and protein intake by entering the food records into a computerized version of a food composition table, Dietist XP. |
| Change in Quality of life | At day 0, 35 and 70 | Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL). |
Countries
Norway
Outcome results
None listed