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

NCT02029079 | Completed

• 1 other identifier: 2013/962
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Malnutrition

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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

Secondary Outcomes (2)

• Change in Nutritional intake

  At day 0, 35 and 70

• Change in Quality of life

  At day 0, 35 and 70

Study Arms (2)

E+ drink, enriched with energy and nutrients.

EXPERIMENTAL

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.

Dietary Supplement: E+

Control

NO INTERVENTION

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

Interventions

E+ DIETARY_SUPPLEMENT

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

E+ drink, enriched with energy and nutrients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Home Care Services

Bergen, 5000, Norway

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Randi J Tangvik, PhD-student

  Clinical Dietitian at Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 7, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

NO (1)