COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.
COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.
NCT ID: NCT02251496 Phase: NA Status: COMPLETED Enrollment: 34 Completion: 2017-12
Conditions
Malnutrition
Interventions
In between meals snacks (Snacks-group), Oral nutrition supplement (ONS-group)
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
Primary Outcome
Weight Changes