KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

NCT ID: NCT06535815

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-03-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Control: Conventional continuous enteral nutrition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Sandra Emily Stoll

Dr., Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernd W Böttiger, Prof

Role: STUDY_DIRECTOR

University Hospital Cologne

Locations

Department of Anesthesiology and Intensive Care Medicine

Cologne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sandra E Stoll, MD, assProf.

Role: CONTACT

sandraemilystoll@googlemail.com

+49221478 ext. 82054

Fabian Dusse, PD, MD

Role: CONTACT

fabian.dusse@uk-koeln.de

+49221478 ext. 40806

Facility Contacts

Sandra E Stoll, MD

Role: primary

sandraemilystoll@googlemail.com

+491735697566

Sandra E Stoll, MD

Role: backup

sandra-emily.stoll@gmx.de

+491735697566 ext. Stoll

Other Identifiers

22-1398_1

Identifier Type: -

Identifier Source: org_study_id