The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition

Haukeland University Hospital

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: E+

Study type: Interventional

Funder types: Other

Identifiers

NCT02029079

2013/962

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

E+ drink, enriched with energy and nutrients.

Experimental group

Description:

The intervention consists of 300 ml E+ per day for 35 days in addition to a normal food intake. This means 525 kcal, and 22.5 gram protein extra per day for five weeks.

Treatment:

Dietary Supplement: E+

Control

No Intervention group

Description:

Subjects in the control group will be assessed in the same way and same time as the intervention group.