Cyclic daytime feeding with nighttime fasting for ICU patients
KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.
This study tests if feeding ICU patients during the day and having them fast at night can help them recover better by improving muscle mass and reducing inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 1 site (Cologne, North Rhine-Westphalia) |
| Trial ID | NCT06535815 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cyclic enteral feeding during the day combined with nighttime fasting on critically ill patients in the ICU. The approach aims to leverage the body's natural circadian rhythms to enhance recovery processes, potentially improving muscle mass and reducing inflammation. Participants will receive enteral nutrition for 12 hours followed by a 12-hour fasting period, supplemented with exogenous ketone salts to support metabolic responses. The outcomes will be measured through various health metrics, including muscle mass maintenance and length of ICU stay.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients admitted to the ICU who require enteral nutrition.
Not a fit: Patients with severe liver or kidney dysfunction, metabolic disorders, or contraindications to enteral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for critically ill patients by enhancing muscle preservation and reducing inflammation.
How similar studies have performed: Previous studies have shown promising results with fasting-mimicking interventions, suggesting that this cyclic feeding approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cologne, North Rhine-Westphalia
- Department of Anesthesiology and Intensive Care Medicine — Cologne, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Sandra E Stoll, MD, assProf.
- Email: sandraemilystoll@googlemail.com
- Phone: +49221478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.