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Intermittent FastingENNUT-CINCT06330610

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

A study testing Intermittent enteral nutrition in people with Intermittent Fasting and Septic Shock, run by University Hospital, Rouen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intermittent enteral nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteFrance
Study dates
9 Jul 2024to 2 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 postmenopausal women, a confirmatory diagnosis must be obtained.

Who cannot join

  • Contraindication 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Rouen

    Rouen, France, 76031

Other trials in France

About this study

Official title: Evaluation de l'efficacité du Support Nutritionnel entéral Intermittent Sur la défaillance d'Organes de Patients de réanimation Sous Ventilation assistée ENteral NUTrition - Continue Intermittent

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.

Being tested
Intermittent enteral nutrition
Keywords
Enteral nutrition, Mechanical ventilation, Intermittent fasting, Sepsis shock, Organ failure
Medical subject headings
Intermittent Fasting, Shock, Septic, Multiple Organ Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent enteral nutritionOther

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

Study groups in NCT06330610
Study groupRoleWhat they receive
Intermittent enteral nutritionExperimentalpatients that receive intermittent enteral nutrition.
Receives: Other: Intermittent enteral nutrition
continuous enteral nutritionNo interventionpatients that receive continuous enteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: day-1 (nutrition start) and day-7

Secondary outcomes (11)
  1. evaluation of caloric intake

    evaluation of caloric intake (kcal/day)

    Measured: from day-1 (nutrition start) to day-7

  2. evaluation of protein intake

    evaluation of protein intake (g/kg/day)

    Measured: from day-1 (nutrition start) to day-7

  3. Measurement of nutritionnal status

    measurement of weight (kg)

    Measured: day-1 (nutrition start) and day-7

  4. Evaluation of the digestive tolerance

    Number of vomit (number)

    Measured: from day-1 (nutrition start) to day-7

  5. Evaluation of the nosocomial infections

    Type of infection

    Measured: from day-1 (nutrition start) to day-7

  6. Adverse events

    Number of adverse event

    Measured: from day-1 (nutrition start) to day-7

  7. Evaluation of the metabolic response

    metabolomics analysis (96 proteins assay)

    Measured: day 1, day 4 and day 7

  8. Evaluation of the duration of hospitalisation

    number of days at hospital

    Measured: day 1 to day 90

  9. Evaluation of the intensive care neuromuscular weakness

    MRC score

    Measured: Up to day 10

  10. Evaluation of death

    Death data collection

    Measured: from day 1 to day 90

  11. Evaluation of quality of life

    SF-36 score

    Measured: up to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start9 Jul 2024
  3. Primary completion2 Aug 2026
  4. Study completion2 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06330610
Sponsor's protocol ID
2021/0378/HP
Acronym
ENNUT-CI
Status last verified
Sep 2026
First submitted
1 Mar 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent enteral nutrition in people with Intermittent Fasting and Septic Shock, run by University Hospital, Rouen at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. (time frame: day-1 (nutrition start) and day-7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06330610, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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