The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
E+
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition
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
Sites / Locations
- Home Care Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
E+ drink, enriched with energy and nutrients.
Control
Arm 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.
Subjects in the control group will be assessed in the same way and same time as the intervention group.
Outcomes
Primary Outcome Measures
Change in Hand grip strength
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
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
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 Outcome Measures
Change in Nutritional intake
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
Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL).
Full Information
NCT ID
NCT02029079
First Posted
December 18, 2013
Last Updated
January 10, 2014
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02029079
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E+ drink, enriched with energy and nutrients.
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects in the control group will be assessed in the same way and same time as the intervention group.
Intervention Type
Dietary Supplement
Intervention Name(s)
E+
Intervention Description
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
Primary Outcome Measure Information:
Title
Change in Hand grip strength
Description
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.
Time Frame
Assessment at day 0, 35 and 70.
Title
Change in Body weight
Description
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.
Time Frame
At day 0, 35 and 70
Title
Change in Body composition
Description
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.
Time Frame
At day 0, 35 and 70
Secondary Outcome Measure Information:
Title
Change in Nutritional intake
Description
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.
Time Frame
At day 0, 35 and 70
Title
Change in Quality of life
Description
Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL).
Time Frame
At day 0, 35 and 70
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi J Tangvik, PhD-student
Organizational Affiliation
Clinical Dietitian at Haukeland University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Home Care Services
City
Bergen
ZIP/Postal Code
5000
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
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