KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Cologne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
written informed consent to participate in this study
admission to ICU
enteral nutrition
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
Other intervention12 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Interventional: Cyclic enteral nutrition with ketogenic nighttime fastingActive comparator 1 intervention
Group B: Control: Conventional continuous enteral nutritionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Loss of muscle mass
Loss of muscle mass via Ultrasound of M. rectus femoris of a predefined leg
Time frame
From date of randomization until the date of ICU discharge up to 1 month2
Progress of urea / creatinine ratio
Urea / creatinine ratio in the patients´ blood
Time frame
From date of randomization until the date of ICU discharge up to 1 monthSecondary outcomes
1
Length of invasive and noninvasive ventilation
Length of invasive and noninvasive ventilation
Time frame
From date of randomization until the date of ICU discharge up to 1 month2
Length of ICU and hospital stay
Length of ICU and hospital stay
Time frame
From date of randomization until the date of hospital discharge up to 6 months3
30 day mortality on day 30
30 day mortality on day 30
Time frame
From date of randomization 30 days4
ICU mobility scale on discharge
ICU mobility scale (lowest score 0, highest score 10)
Time frame
From date of randomization until the date of ICU discharge up to 1 monthSponsors and contacts
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Source ClinicalTrials.gov