The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
NCT ID: NCT02029079
Last Updated: 2014-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2013-08-31
2013-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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E+ drink, enriched with energy and nutrients.
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.
E+
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
Control
Subjects in the control group will be assessed in the same way and same time as the intervention group.
No interventions assigned to this group
Interventions
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E+
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Randi J Tangvik, PhD-student
Role: STUDY_CHAIR
Clinical Dietitian at Haukeland University Hospital
Locations
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Home Care Services
Bergen, , Norway
Countries
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Other Identifiers
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2013/962
Identifier Type: -
Identifier Source: org_study_id
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