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Recruiting NCT06535815

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

Trial Parameters

Condition Nutrition
Sponsor University Hospital of Cologne
Study Type INTERVENTIONAL
Phase N/A
Enrollment 130
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-01
Completion 2025-12-31
Interventions
Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)

Brief 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 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

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