Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535815
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
KetoNiFast Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
KetoNiFast Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KetoNiFast
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 ureacreatinine ration length of ventilation length of ICU and hospital stay 30-day mortality ICU mobility scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None