Introduction Intervention studies have mainly used oral nutritional supplements (ONS) for the management of patients with chronic obstructive pulmonary disease (COPD) identified as at nutritional risk. In this 12-month randomised feasibility trial, we assessed the (1) feasibility of the recruitment, retention and provision of two interventions: ONS and between-meal snacks (snacks) and (2) the potential impact of the provision of snacks and ONS on body weight and quality of life in patients with COPD.
Methods Hospitalised patients with COPD, at nutritional risk, were randomised to ONS (n=19) or snacks (n=15) providing 600 kcal and 22 g protein a day in addition to regular daily diet. The intervention started in hospital and was continued for 12 months after discharge from the hospital.
Results Study recruitment rate was n=34 (45%) and retention rate at 12 months was similar for both groups: n=13 (68%) in the ONS group and n=10 (67%) in the Snacks group. Both groups gained weight from baseline to 12 months (2.3±4.6 kg (p=0.060) in the ONS group and 4.4±6.4 kg (p=0.030) in the Snacks group). The St George’s Respiratory Questionnaire total score improved from baseline to 12 months in both groups (score 3.9±11.0 (p=0.176) in the ONS group and score 8.9±14.1 (p=0.041) in the Snacks group).
Discussion In patients with COPD who are at nutritional risk snacks are at least as feasible and effective as ONS, however, adequately powered trials that take account of the difficulties in recruiting this patient group are required to confirm this effect.
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Contributors Concept and design of study: ARI, IG, AMB, CB, AR, TG and OGG. Data collection and data management: ARI. Analysing and interpretation of data: ARI, IG, AMB, CB, CEW, AR, TG and OGG. Writing the manuscript: ARI. All authors participated in editing and final revisions of the manuscript. All authors have read and approved the final manuscript.
Funding This paper presents independent research that was supported by the Icelandic Research Fund of the Icelandic Centre for Research (141216-051), the Eimskip University Fund and the Landspitali University Hospital Research Fund. Oral nutritional supplements were partly funded by Nutricia (Icepharma) and between meals by MS Iceland Dairies (Mjólkursamsalan).
Disclaimer The views expressed in this study are those of the authors and not necessarily those of the funding source.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The study was approved by the National Bioethics Committee (VSN14-066-S1), Chief Medical Officer Landspitali (LSH 68-14) and Data Protection Authority (2014/908).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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