ClinicalTrials.gg
CompletedNCT06330610ENNUT-CIUpdated Nov 6, 2026

Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit

An interventional study of Intermittent enteral nutrition in Intermittent Fasting, Septic Shock and Organ Failure, Multiple, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Supportive care

Updated Sep 28, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.

Read the detailed description

Some pre-clinical and observational studies have suggested that intermittent fasting may have a positive impact on patients in ICU by increasing protein synthesis, sensibility to insulin, cetogenesis, autophagy by respecting the circadian rhythm. This study aims to evaluate the impact on organ failures of an intermittent enteral nutrition versus continuous enteral nutrition in patients at the acute phase of sepsis shock with mechanical ventilation in the ICU.

02

Conditions studied

  • Intermittent Fasting
  • Septic Shock
  • Organ Failure, Multiple

Keywords

  • Enteral nutrition
  • Mechanical ventilation
  • Intermittent fasting
  • Sepsis shock
  • Organ failure
03

In context

Intermittent Fasting

333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.

This study's enrollment of 174 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.

Browse Intermittent Fasting studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient admitted in ICU for less than 48h, with invasive mechanical ventilation predicted for at least 48h, that can undergo nasogastric feeding for 7 days.
  • Patient under vasopressive drugs
  • Adult patients (age ≥ 18 years)
  • Informed person who has read and signed their consent

    • If the patient is unable to sign their consent (emergency situation), the consent will be signed by a trusted person or a family member, and consent to continue the study will be requested subsequently.
    • If the patient is unable to sign their consent (emergency situation) and no trusted person is present, the patient may be included in the study. In this case, consent to continue the study will be requested from a trusted person as soon as possible, or from the patient if they are able to understand and sign the consent.
  • Affiliation to a social security scheme
  • No current pregnancy: for women of childbearing age, a beta-HCG blood pregnancy test will be performed upon inclusion; for women, a confirmatory diagnosis must be obtained.

Exclusion criteria

Exclusion Criteria:

  • to enteral nutrition and/or nasogastric tube insertion: esophageal varices and occlusive syndrome
  • Artificial enteral nutrition that cannot be initiated within 48 hours of intubation
  • Enteral nutrition ongoing for more than one hour at the time of inclusion
  • Need for exclusive or supplemental parenteral nutrition
  • Moribund patient
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
  • Pregnant or breastfeeding woman
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (actual)

Study arms

  • Experimental
    Intermittent enteral nutrition

    patients that receive intermittent enteral nutrition.

    Other: Intermittent enteral nutrition

  • No intervention
    continuous enteral nutrition

    patients that receive continuous enteral nutrition

Interventions

  • OtherIntermittent enteral nutrition

    Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours.

06

What researchers measure

Primary outcomes

  1. Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.

    Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition.

    Time frame: day-1 (nutrition start) and day-7

Secondary outcomes

  1. evaluation of caloric intake

    evaluation of caloric intake (kcal/day)

    Time frame: from day-1 (nutrition start) to day-7

  2. evaluation of protein intake

    evaluation of protein intake (g/kg/day)

    Time frame: from day-1 (nutrition start) to day-7

  3. Measurement of nutritionnal status

    measurement of weight (kg)

    Time frame: day-1 (nutrition start) and day-7

  4. Evaluation of the digestive tolerance

    Number of vomit (number)

    Time frame: from day-1 (nutrition start) to day-7

  5. Evaluation of the nosocomial infections

    Type of infection

    Time frame: from day-1 (nutrition start) to day-7

  6. Adverse events

    Number of adverse event

    Time frame: from day-1 (nutrition start) to day-7

  7. Evaluation of the metabolic response

    metabolomics analysis (96 proteins assay)

    Time frame: day 1, day 4 and day 7

  8. Evaluation of the duration of hospitalisation

    number of days at hospital

    Time frame: day 1 to day 90

  9. Evaluation of the intensive care neuromuscular weakness

    MRC score

    Time frame: Up to day 10

  10. Evaluation of death

    Death data collection

    Time frame: from day 1 to day 90

  11. Evaluation of quality of life

    SF-36 score

    Time frame: up to day 90

07

Study locations

1 site
  • CHU de Rouen
    Rouen, France 76031, France
08

References and documents

Publications

  • Tebani A, Demailly Z, Bekri S, Maizel J, Marchalot A, Bourel C, Du Cheyron D, Michot JB, Schnell G, Vanderlinden T, Tamion F. Clinical and metabolic phenotyping of continuous versus intermittent ENteral NUTrition in ventilated adults with shock: ENNUT trial protocol. BMJ Open. 2025 Aug 1;15(7):e099761. doi: 10.1136/bmjopen-2025-099761. PubMed 40750277 ↗
  • Atherton PJ, Etheridge T, Watt PW, Wilkinson D, Selby A, Rankin D, Smith K, Rennie MJ. Muscle full effect after oral protein: time-dependent concordance and discordance between human muscle protein synthesis and mTORC1 signaling. Am J Clin Nutr. 2010 Nov;92(5):1080-8. doi: 10.3945/ajcn.2010.29819. Epub 2010 Sep 15. PubMed 20844073 ↗
  • McNelly AS, Bear DE, Connolly BA, Arbane G, Allum L, Tarbhai A, Cooper JA, Hopkins PA, Wise MP, Brealey D, Rooney K, Cupitt J, Carr B, Koelfat K, Damink SO, Atherton PJ, Hart N, Montgomery HE, Puthucheary ZA. Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial. Chest. 2020 Jul;158(1):183-194. doi: 10.1016/j.chest.2020.03.045. Epub 2020 Apr 2. PubMed 32247714 ↗
  • Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10. PubMed 32651634 ↗
  • Marcheva B, Ramsey KM, Peek CB, Affinati A, Maury E, Bass J. Circadian clocks and metabolism. Handb Exp Pharmacol. 2013;(217):127-55. doi: 10.1007/978-3-642-25950-0_6. PubMed 23604478 ↗
  • Baggs JE, Hogenesch JB. Genomics and systems approaches in the mammalian circadian clock. Curr Opin Genet Dev. 2010 Dec;20(6):581-7. doi: 10.1016/j.gde.2010.08.009. PubMed 20926286 ↗
  • Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234. PubMed 31151228 ↗
  • Pickel L, Sung HK. Feeding Rhythms and the Circadian Regulation of Metabolism. Front Nutr. 2020 Apr 17;7:39. doi: 10.3389/fnut.2020.00039. eCollection 2020. PubMed 32363197 ↗
  • Gunst J. Recovery from critical illness-induced organ failure: the role of autophagy. Crit Care. 2017 Aug 7;21(1):209. doi: 10.1186/s13054-017-1786-y. PubMed 28784175 ↗
  • Vanhorebeek I, Gunst J, Derde S, Derese I, Boussemaere M, Guiza F, Martinet W, Timmermans JP, D'Hoore A, Wouters PJ, Van den Berghe G. Insufficient activation of autophagy allows cellular damage to accumulate in critically ill patients. J Clin Endocrinol Metab. 2011 Apr;96(4):E633-45. doi: 10.1210/jc.2010-2563. Epub 2011 Jan 26. PubMed 21270330 ↗
  • Hermans G, Casaer MP, Clerckx B, Guiza F, Vanhullebusch T, Derde S, Meersseman P, Derese I, Mesotten D, Wouters PJ, Van Cromphaut S, Debaveye Y, Gosselink R, Gunst J, Wilmer A, Van den Berghe G, Vanhorebeek I. Effect of tolerating macronutrient deficit on the development of intensive-care unit acquired weakness: a subanalysis of the EPaNIC trial. Lancet Respir Med. 2013 Oct;1(8):621-629. doi: 10.1016/S2213-2600(13)70183-8. Epub 2013 Sep 10. PubMed 24461665 ↗
  • Martinez-Lopez N, Tarabra E, Toledo M, Garcia-Macia M, Sahu S, Coletto L, Batista-Gonzalez A, Barzilai N, Pessin JE, Schwartz GJ, Kersten S, Singh R. System-wide Benefits of Intermeal Fasting by Autophagy. Cell Metab. 2017 Dec 5;26(6):856-871.e5. doi: 10.1016/j.cmet.2017.09.020. Epub 2017 Oct 26. PubMed 29107505 ↗
  • Newman JC, Verdin E. beta-Hydroxybutyrate: A Signaling Metabolite. Annu Rev Nutr. 2017 Aug 21;37:51-76. doi: 10.1146/annurev-nutr-071816-064916. PubMed 28826372 ↗
  • Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27. PubMed 27475046 ↗
  • Zou X, Meng J, Li L, Han W, Li C, Zhong R, Miao X, Cai J, Zhang Y, Zhu D. Acetoacetate Accelerates Muscle Regeneration and Ameliorates Muscular Dystrophy in Mice. J Biol Chem. 2016 Jan 29;291(5):2181-95. doi: 10.1074/jbc.M115.676510. Epub 2015 Dec 8. PubMed 26645687 ↗
  • Goossens C, Weckx R, Derde S, Dufour T, Vander Perre S, Pauwels L, Thiessen SE, Van Veldhoven PP, Van den Berghe G, Langouche L. Adipose tissue protects against sepsis-induced muscle weakness in mice: from lipolysis to ketones. Crit Care. 2019 Jul 1;23(1):236. doi: 10.1186/s13054-019-2506-6. PubMed 31262340 ↗
  • Stekovic S, Hofer SJ, Tripolt N, Aon MA, Royer P, Pein L, Stadler JT, Pendl T, Prietl B, Url J, Schroeder S, Tadic J, Eisenberg T, Magnes C, Stumpe M, Zuegner E, Bordag N, Riedl R, Schmidt A, Kolesnik E, Verheyen N, Springer A, Madl T, Sinner F, de Cabo R, Kroemer G, Obermayer-Pietsch B, Dengjel J, Sourij H, Pieber TR, Madeo F. Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans. Cell Metab. 2019 Sep 3;30(3):462-476.e6. doi: 10.1016/j.cmet.2019.07.016. Epub 2019 Aug 27. PubMed 31471173 ↗
  • de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available. PubMed 31881139 ↗
  • Thiessen SE, Van den Berghe G, Vanhorebeek I. Mitochondrial and endoplasmic reticulum dysfunction and related defense mechanisms in critical illness-induced multiple organ failure. Biochim Biophys Acta Mol Basis Dis. 2017 Oct;1863(10 Pt B):2534-2545. doi: 10.1016/j.bbadis.2017.02.015. Epub 2017 Feb 17. PubMed 28219766 ↗
  • Van Dyck L, Casaer MP. Intermittent or continuous feeding: any difference during the first week? Curr Opin Crit Care. 2019 Aug;25(4):356-362. doi: 10.1097/MCC.0000000000000617. PubMed 31107308 ↗
  • Deane AM, Chapman MJ, Reintam Blaser A, McClave SA, Emmanuel A. Pathophysiology and Treatment of Gastrointestinal Motility Disorders in the Acutely Ill. Nutr Clin Pract. 2019 Feb;34(1):23-36. doi: 10.1002/ncp.10199. Epub 2018 Oct 7. PubMed 30294835 ↗
  • Van Dyck L, Vanhorebeek I, Wilmer A, Schrijvers A, Derese I, Mebis L, Wouters PJ, Van den Berghe G, Gunst J, Casaer MP. Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study. Crit Care. 2020 May 24;24(1):249. doi: 10.1186/s13054-020-02987-3. PubMed 32448392 ↗
  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29. PubMed 30348463 ↗

Individual participant data

Plan to share: Undecided

09

Updates

2 registry updates since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 28, 2026
Primary completion
Oct 9, 2027→Aug 2, 2026 (actual)
Sep 28, 2026
Study completion
Oct 9, 2027→Aug 2, 2026 (actual)
Sep 28, 2026
Show all 2 updates
  1. Nov 6, 2026
    Minor edits only
    + 1 other change: references
  2. Sep 28, 2026
    Recruiting→Completed
    Primary completion Oct 9, 2027→Aug 2, 2026 (now actual)
    Study completion Oct 9, 2027→Aug 2, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06330610
Collaborators
University Hospital, Lille, University Hospital, Caen, Amiens University Hospital, Centre Hospitalier Saint-Philibert, GHICL, Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil, Groupe Hospitalier du Havre, Centre Hospitalier de Dieppe
Responsible party
Sponsor
First posted
Mar 26, 2024
Start date
Jul 9, 2024
Primary completion
Aug 2, 2026
Completion
Aug 2, 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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