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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cologne, Nrw, Germany
Patients applied
Trial Officials
Bernd W Böttiger, Prof
Study Director
University Hospital Cologne
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported