Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate in this study
- Admission to ICU
- Receiving enteral nutrition
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
Trial Site Locations
Total: 1 location
1
Department of Anesthesiology and Intensive Care Medicine
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
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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