Does intermittent nutrition enterally normalise hormonal and metabolic responses to feeding in critically ill adults? A protocol for the dine-normal proof-of-concept randomised parallel group study
Beattie, Clodagh Emer; Thomas, Matt; Borislavova, Borislava; Smith, Harry A; Ambler, Michael; White, Paul; Hayes, Kati; Milne, Danielle; Ramesh, Aravind V; Gonzalez, Javier T; Betts, James A; Pickering, Anthony E
Authors
Clodagh Emer Beattie
Matt Thomas
Borislava Borislavova
Harry A Smith
Michael Ambler
Paul White Paul.White@uwe.ac.uk
Professor in Applied Statistics
Kati Hayes
Danielle Milne
Aravind V Ramesh
Javier T Gonzalez
James A Betts
Anthony E Pickering
Abstract
Introduction
Over half of patients who spend >48 hours in the intensive care unit (ICU) are fed via a nasogastric (NG) tube. Current guidance recommends continuous delivery of feed throughout the day and night. Emerging evidence from healthy human studies shows that NG feeding in an intermittent pattern (rather than continuous) promotes phasic hormonal, digestive and metabolic responses that are important for effective nutrition. It is not yet known whether this will translate to the critically ill population. Here we present the protocol for a proof-of-concept study comparing diurnal intermittent versus continuous feeding on hormonal and metabolic outcomes for patients in the intensive care unit.
Methods and Analysis
The study is a single-centre, prospective, randomised, open-label trial comparing intermittent enteral nutrition with the current standard practice of continuous enteral feeding. It aims to recruit participants (n=30) needing enteral nutrition via an NG tube for >24 hours who will be randomised to a diurnal intermittent or a continuous feeding regime with equivalent nutritional value. The primary outcome is peak plasma insulin / c-peptide within 3 hours of delivering the morning intermittent feed on the second study day, compared to that seen in the continuous feed delivery group at the same timepoint. Secondary outcomes include feasibility, tolerability, efficacy and metabolic / hormonal profiles.
Ethics and Dissemination
This trial has been registered prospectively with the Clinical Trials Registry (clinicaltrials.gov - NCT06115044). We obtained ethical approval from the Wales Research Ethics Committee 3 prior to data collection (reference 23/WA/0297). We will publish the results of this study in an open-access peer-reviewed journal.
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Does intermittent nutrition enterally normalise hormonal and metabolic responses to feeding in critically ill adults? A protocol for the DINE-Normal proof-of-concept randomised parallel-group study.
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