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COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.

NCT02251496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-01-19

Study results available
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Summary

At least one fifth of patients in European hospitals are malnourished. Malnutrition is associated with negative consequences, including higher rates of complications, longer hospital stay, impaired wound healing and increased mortality with consequent effects on costs of healthcare. Evidence suggests that there may be benefits to some malnourished patients from receiving oral nutrition supplements in the short-term but it is not known whether these benefits can be sustained and indeed whether similar benefits may be achieved using food-based interventions of lower cost. The overall objective of the study is to compare two nutritional interventions among malnourished patients with COPD (n=200); oral nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is weight change. Secondary endpoints include forced expiratory volume in one second, forced vital capacity, six-minute walk distance, hand-grip strength, health related quality of life, length of hospital stay, energy- and protein intake, readmissions to the hospital and acute exacerbation. No studies are available comparing the supply of ONS to malnourished patients with COPD compared with the provision of regular food (in-between meals snacks). The results of the study will provide important information that might improve nutrition care in the hospital setting as well as after discharge from the hospital

Conditions

  • Malnutrition

Interventions

OTHER

In between meals snacks (Snacks-group)

In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).

OTHER

Oral nutrition supplement (ONS-group)

The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).

Sponsors & Collaborators

  • University of Iceland

    lead OTHER

Principal Investigators

  • Áróra R Ingadóttir, Master · Unit for Nutrition Research (UNR)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251496 on ClinicalTrials.gov