KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Loss of muscle mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Loss of muscle mass
Time Frame: From date of randomization until the date of ICU discharge up to 1 month
Loss of muscle mass via Ultrasound of M. rectus femoris of a predefined leg
Progress of urea / creatinine ratio
Time Frame: From date of randomization until the date of ICU discharge up to 1 month
Urea / creatinine ratio in the patients´ blood
Secondary Outcomes
- 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)
Investigators
Sandra Emily Stoll
Dr., Assistant Professor
University Hospital of Cologne