CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
In between meals snacks (Snacks-group) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02251496
NCT02251496N/ACompleted

Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks, Weight Changes and Functional Capacity in Chronic Obstructive Pulmonary Disease; Randomized Controlled Dietary Intervention

University of Iceland·interventional·Posted Sep 29, 2014·Updated Jan 19, 2021

In Brief

A clinical study evaluating In between meals snacks (Snacks-group) and Oral nutrition supplement (ONS-group) for Malnutrition. Completed, enrolled 34 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalnutrition
CountriesIceland
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 29, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.8 years ago

Interventions

In between meals snacks (Snacks-group)other

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).

Oral nutrition supplement (ONS-group)other

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).