The DINE-Normal Proof-of-concept Study

NCT06115044 | Completed

• 2 other identifiers: R&D 5454IRAS 328469
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Overarching hypothesis In critically ill adults enteral feeding in a diurnal intermittent pattern improves patient centred outcomes. Research questions for this study Are the same derangements in metabolic and hormonal function observed in healthy volunteers when fed continuously via a nasogastric tube observed in critically ill patients and can those derangements be mitigated by intermittent diurnal feeding? Aim of this study Assess the effect of an enteral nutrition regimen mimicking the usual diurnal meal pattern on hormonal profile and metabolism in critically ill adults. This will generate novel and important proof of concept data and support progression to a clinical trial integrating investigation of physiological responses and patient centred outcomes. Objectives of this study Laboratory: Characterise patterns of hormone, lipid and metabolite response to intermittent diurnal feeding in critically ill adults. Clinical: assess feasibility, tolerability (vomiting and gastric residual volume) and efficacy (calorie delivery) of intermittent diurnal feeding in critically ill adults.

Conditions

Critical Illness; Enteral Nutrition; Time Restricted Feeding

Outcome Measures

Primary Outcomes (1)

• Insulin

  Plasma insulin and C-Peptide

  Peak within 3 hours of bolus feed (comparable time point in comparator)

Secondary Outcomes (12)

• Urea

  Study day 1 and study day 2

• Glucagon-like peptide 1

  Study day 1 and study day 2

• Ketones

  Study day 1 and study day 2

• Non-esterified fatty acids

  Study day 1 and study day 2

• Triglyceride

  Study day 1 and study day 2

Study Arms (2)

Intermittent

EXPERIMENTAL

Bolus feeding over 30 to 60 minutes at 0800, 1300 and 1800

Procedure: Intermittent diurnal nutrition

Continuous

ACTIVE COMPARATOR

Continuous feeding over 24 hours

Procedure: Continuous

Interventions

Intermittent diurnal nutrition PROCEDURE

Calculated daily nutritional requirement given as three equal bolus feeds in daytime with prolonged overnight fast

Intermittent

Continuous PROCEDURE

Calculated daily nutritional requirement given over 24 hours

Continuous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18) on intensive care
• Planned for gastric enteral nutrition (anticipated duration \>48 hours)

You may not qualify if:

• \>24 hours after commencement of enteral nutrition
• Gastrointestinal surgery or pathology
• Diabetic emergencies
• Pregnancy
• Parenteral or jejunal nutrition
• Trophic feed only
• Prone positioning
• High risk of refeeding syndrome

Sponsors & Collaborators

• North Bristol NHS Trust: lead
• University of Bath: collaborator
• University of Bristol: collaborator
• University of the West of England: collaborator

Study Sites (1)

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Related Publications (2)

• Beattie CE, Borislava B, Smith HA, Ambler MT, White P, Milne D, Ramesh AV, Ferriman A, Fisher T, Horsley C, Jackson S, Jubainville C, Lobo K, Maxfield H, Gonzalez JT, Betts JA, Pickering AE, Thomas M. Does Intermittent Nutrition Enterally Normalise hormonal and metabolic responses to feeding in critically ill adults? The DINE-normal proof-of-concept study. Clin Nutr. 2025 Dec;55:81-89. doi: 10.1016/j.clnu.2025.10.003. Epub 2025 Oct 30.

  PMID: 41197596 DERIVED

• Beattie CE, Thomas M, Borislavova B, Smith HA, Ambler M, White P, Hayes K, Milne D, Ramesh AV, Gonzalez JT, Betts JA, Pickering AE. 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. BMJ Open. 2024 Nov 24;14(11):e086540. doi: 10.1136/bmjopen-2024-086540.

  PMID: 39581721 DERIVED

MeSH Terms

Conditions

Critical Illness; Intermittent Fasting

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Matt Thomas

  North Bristol NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Intensive Care Medicine

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: December 27, 2023
• Primary Completion: April 24, 2024
• Study Completion: October 31, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)