KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

University Hospital of Cologne

Status: Enrolling

Conditions: Nutrition; Inflammatory Response; Muscle Loss

Treatments: Other: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT06535815

22-1398_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting

Active Comparator group

Description:

Interventional group: 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.

Treatment:

Other: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)

Control: Conventional continuous enteral nutrition

No Intervention group

Description:

Control group Continuous enteral nutrition for 24 hours (as per patients´ individual caloric requirements defined by indirect calorimetry).