Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06535815

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

Led by University Hospital of Cologne · Updated on 2024-08-06

130

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent to participate in this study
  • Admission to ICU
  • Receiving enteral nutrition
Not Eligible

You will not qualify if you...

  • Severe liver dysfunction or liver failure (Child Pugh >7 points / category B)
  • Severe kidney dysfunction (KDIGO stage 3)
  • Total pancreatectomy or insulin dependent diabetes mellitus (IDDM)
  • Pregnancy or lactation
  • Hemoglobin concentration less than 80 g/l
  • Severe metabolic disorders or 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 or cardiomyopathy
  • Contraindication against enteral nutrition
  • Lack of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Anesthesiology and Intensive Care Medicine

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

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Research Team

S

Sandra E Stoll, MD, assProf.

CONTACT

F

Fabian Dusse, PD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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