RecruitingNot ApplicableNCT06535815

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.


Sponsor

University Hospital of Cologne

Enrollment

130 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • written informed consent to participate in this study
  • admission to ICU
  • enteral nutrition

Exclusion Criteria14

  • Severe liver dysfunction / liver failure (Child Pugh >7 points / category B)
  • Severe kidney dysfunction (KDIGO stage 3)
  • Total pancreatectomy / insulin dependent diabetes mellitus (IDDM)
  • Pregnancy / lactation
  • Hemoglobin concentration < 80g/l
  • Severe metabolic disorders / severe autoimmune diseases
  • Refractory metabolic or respiratory acidosis
  • Dysfunction of mitochondrial transport of fatty acids
  • Dysfunction of oxidation of fatty acids
  • Dysfunction of gluconeogenesis, production and reduction of ketones
  • Intermittent Porphyria
  • Severe cardiac arrhythmias / cardiomyopathy
  • Contraindication against enteral nutrition
  • Lack of informed consent

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERCyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)

12 hours of enteral feeding (as per patients´individual calorimetric requirements measured by indirect calorimetry) followed by a fasting period of 12 hours supported by the supplementation of exogenous ketone salts.


Locations(1)

Department of Anesthesiology and Intensive Care Medicine

Cologne, North Rhine-Westphalia, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06535815


Related Trials