KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
Recruiting now · Not applicable
Conditions studied: Nutrition, Muscle Loss, Inflammatory Response
In brief
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.
Key facts
- Study ID
- NCT06535815
- Run by
- University Hospital of Cologne
- People needed
- 130
- Starts
- 2023-09-01
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- written informed consent to participate in this study
- admission to ICU
- enteral nutrition
You may not qualify if…
- 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 it is running
- Department of Anesthesiology and Intensive Care Medicine — Cologne, North Rhine-Westphalia, Germany (enrolling)
Full record on ClinicalTrials.gov
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