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.

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 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 bolus 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06115044

Funding Statement

This study is funded by the Southmead Hospital Charity Research Fund. AEP and MTA are supported by MRC funding for studies of metabolism related to ICU care (MR/W029138/1).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Cardiff Research Ethics Committee 3 (reference 23/WA/0297) of the Health Research Authority gave ethical approval for this work

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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