KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

NCT06535815 | Recruiting

• 1 other identifier: 22-1398_1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition; Muscle Loss; Inflammatory Response

Keywords

Ketogenic diet; ketogenic fasting; cyclic enteral nutrition

Outcome Measures

Primary Outcomes (2)

• Loss of muscle mass

  Loss of muscle mass via Ultrasound of M. rectus femoris of a predefined leg

  From date of randomization until the date of ICU discharge up to 1 month

• Progress of urea / creatinine ratio

  Urea / creatinine ratio in the patients´ blood

  From date of randomization until the date of ICU discharge up to 1 month

Secondary Outcomes (4)

• Length of invasive and noninvasive ventilation

  From date of randomization until the date of ICU discharge up to 1 month

• Length of ICU and hospital stay

  From date of randomization until the date of hospital discharge up to 6 months

• 30 day mortality on day 30

  From date of randomization 30 days

• ICU mobility scale on discharge

  From date of randomization until the date of ICU discharge up to 1 month

Study Arms (2)

Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting

ACTIVE COMPARATOR

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.

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

Control: Conventional continuous enteral nutrition

NO INTERVENTION

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

Interventions

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

Also known as: cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation

Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Bernd W Böttiger, Prof

  University Hospital Cologne

  STUDY DIRECTOR

Central Study Contacts

Sandra E Stoll, MD, assProf.

CONTACT

+49221478; sandraemilystoll@googlemail.com

Fabian Dusse, PD, MD

CONTACT

+49221478; fabian.dusse@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Assistant Professor

Model Details: Monocentric, prospective, randomized, interventional trial

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)