NCT06535815

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University Hospital of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is increasing evidence that a circadian rhythm of feeding (cyclic feeding) could be beneficial for critical ill patients. Cyclic feeding and fasting are assumed to have positive effects on the gut microbiome resulting in optimization of host responses to gastrointestinal pathogens. Another positive effect of cyclic feeding potentially results from activation of a "fasting response", inducing repair pathways such as ketogenesis, mitochondrial biogenesis, anti-inflammatory pathways, antioxidant defenses and autophagy processes. The activation of these repair pathways could diminish cellular stress and promote cellular recovery in critical ill patients. A randomized controlled trial by van Dyck et al. could show that fasting-mimicking intervals of 12 hours are sufficient to generate a metabolic fasting response without risking a caloric deficit. This fasting response can be enhanced by additional supplementation of exogenous ketones. A cyclic enteral nutrition with 12 hours of daytime feeding and 12 hours of ketogenic nighttime fasting compared to a continuous enteral feeding for 24 hours can potentially improve the reconstitution of critically ill Intensive Care patients. This improved reconstitution can be measured by maintenance of muscle mass (measured by ultrasound of the musculus rectus femoris), urea/creatinine ration, length of ventilation, length of ICU and hospital stay, 30-day mortality, ICU mobility scale.

Conditions

• Nutrition
• Muscle Loss
• Inflammatory Response

Interventions

Type	Name	Description
OTHER	Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)	12 hours of enteral feeding (as per patients´individual calorimetric requirements measured by indirect calorimetry) followed by a fasting period of 12 hours supported by the supplementation of exogenous ketone salts.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2024-08-02
• Last updated: 2024-08-06

Locations

1 site across 1 country: Germany