Clinical trial NCT02029079: The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
Official title: The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hand grip strength
timeFrame: Assessment at day 0, 35 and 70.
measure: Change in Body weight
timeFrame: At day 0, 35 and 70
measure: Change in Body composition
timeFrame: At day 0, 35 and 70
Secondary outcomes:
measure: Change in Nutritional intake
timeFrame: At day 0, 35 and 70
measure: Change in Quality of life
timeFrame: At day 0, 35 and 70
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Home Care Services
Study officials:
affiliation: Clinical Dietitian at Haukeland University Hospital
name: Randi J Tangvik, PhD-student
role: STUDY_CHAIR
References: