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

• Published in: BMJ open 2024-11, Vol.14 (11), p.e086540
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adult; Adult intensive & critical care; Adults; Autophagy; C-Peptide - blood; Circadian rhythm; Constipation; Cost control; Critical Illness - therapy; Delirium; Enteral nutrition; Enteral Nutrition - methods; Fasting; Hormones; Humans; Insulin; Insulin - blood; INTENSIVE & CRITICAL CARE; Intensive Care; Intensive Care Units; Intubation, Gastrointestinal - methods; Metabolism; Metabolites; Mortality; Musculoskeletal system; Nutrition; NUTRITION & DIETETICS; Patients; Peptides; Proof of Concept Study; Prospective Studies; Proteins; Protocol; Randomized Controlled Trial; Randomized Controlled Trials as Topic; Standard of care
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-086540

IntroductionOver 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 vs continuous feeding on hormonal and metabolic outcomes for patients in the ICU.Methods and analysisThe 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 regimen 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 with that seen in the continuous feed delivery group at the same time point. Secondary outcomes include feasibility, tolerability, efficacy and metabolic/hormonal profiles.Ethics and disseminationWe 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.Trial registration number NCT06115044.