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Completed

NCT Number: NCT02029079

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Home Care Services

Bergen, 5000, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E+

Dietary Supplement

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

Primary outcomes

  1. Change in Hand grip strength

    Time frame: Assessment at day 0, 35 and 70.

    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.

  2. Change in Body weight

    Time frame: At day 0, 35 and 70

    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.

  3. Change in Body composition

    Time frame: At day 0, 35 and 70

    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 outcomes

  1. Change in Nutritional intake

    Time frame: At day 0, 35 and 70

    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.

  2. Change in Quality of life

    Time frame: At day 0, 35 and 70

    Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL).

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2014
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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