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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029079
• Other study ID #: 2013/962
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: January 10, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• E+
300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.

Locations

Country	Name	City	State
Norway	Home Care Services	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment at day 0, 35 and 70.	No
Primary	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.	At day 0, 35 and 70	No
Primary	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.	At day 0, 35 and 70	No
Secondary	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.	At day 0, 35 and 70	No
Secondary	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).	At day 0, 35 and 70	No