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The DINE-Normal Proof-of-concept Study

NCT06115044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-25

No results posted yet for this study

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

Interventions

PROCEDURE

Intermittent diurnal nutrition

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

PROCEDURE

Continuous

Calculated daily nutritional requirement given over 24 hours

Sponsors & Collaborators

  • University of Bath

    collaborator OTHER

  • University of Bristol

    collaborator OTHER

  • University of the West of England

    collaborator OTHER

  • North Bristol NHS Trust

    lead OTHER

Principal Investigators

  • Matt Thomas · North Bristol NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2024-04-24
Completion
2024-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06115044 on ClinicalTrials.gov