CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Intermittent diurnal nutrition +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06115044
NCT06115044N/ACompleted

Does Intermittent Nutrition Enterally Normalise Hormonal and Metabolic Responses to Feeding in Critically Ill Adults: The DINE-Normal Proof-of-concept Study

North Bristol NHS Trust·interventional·Posted Nov 2, 2023·Updated May 25, 2025

In Brief

A clinical study evaluating Intermittent diurnal nutrition and Continuous for Critical Illness and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
202420252026
First PostedNov 2, 2023
Enrollment StartDec 27, 2023
Primary CompletionApr 24, 2024
Study CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.7 years ago

Interventions

Intermittent diurnal nutritionprocedure

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

Continuousprocedure

Calculated daily nutritional requirement given over 24 hours