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Search / Trial NCT06535815

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

Launched by UNIVERSITY HOSPITAL OF COLOGNE · Jul 30, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ketogenic Diet Ketogenic Fasting Cyclic Enteral Nutrition

ClinConnect Summary

The KetoNiFast trial is studying a new way to provide nutrition to patients in the Intensive Care Unit (ICU). This study looks at the effects of feeding patients during the day while allowing them to fast at night. The idea is that fasting at night, which is a natural process for our bodies, may help with recovery by supporting healing and reducing inflammation. Instead of continuous feeding, participants will receive nutrition for 12 hours followed by a 12-hour fasting period, combined with special supplements called ketone salts.

To be eligible for the trial, patients must be admitted to the ICU and agree to participate by providing written consent. However, certain health conditions could exclude them, such as severe liver or kidney issues, pregnancy, or severe metabolic disorders. Participants can expect to follow this new feeding schedule while their health is monitored, and the results may help improve nutrition strategies for critically ill patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • written informed consent to participate in this study
  • admission to ICU
  • enteral nutrition
  • Exclusion Criteria:
  • 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

About University Hospital Of Cologne

The University Hospital of Cologne is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields, collaborating with multidisciplinary teams to conduct rigorous investigations that enhance patient care and contribute to the development of new therapeutic strategies. With state-of-the-art facilities and a strong emphasis on education and training, the University Hospital of Cologne is dedicated to fostering a collaborative environment that promotes ethical research practices and improves health outcomes for diverse patient populations.

Locations

Cologne, Nrw, Germany

Patients applied

0 patients applied

Trial Officials

Bernd W Böttiger, Prof

Study Director

University Hospital Cologne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported