NutritionKetoNiFastNCT06535815
KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
A study testing Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) in people with Nutrition and Muscle Loss, run by University Hospital of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition, Muscle Loss, Inflammatory Response
- What is being tested?
- Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent to participate in this study
- admission to ICU
- enteral nutrition
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine
Cologne, North Rhine-Westphalia, 50937
Sandra E Stoll, MD, +491735697566, sandraemilystoll@googlemail.com
Sandra E Stoll, MD, +491735697566 ext. Stoll, sandra-emily.stoll@gmx.de
About this study
Official title: KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.
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.
Read the 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.
- Conditions
- Nutrition, Muscle Loss, Inflammatory Response
- Being tested
- Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
- Keywords
- Ketogenic diet, ketogenic fasting, cyclic enteral nutrition
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Other
Also called cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation
12 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting | Active comparator | Interventional group:
12 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. Receives: Other: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) |
| Control: Conventional continuous enteral nutrition | No intervention | Control group Continuous enteral nutrition for 24 hours (as per patients´ individual caloric requirements defined by indirect calorimetry). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of muscle mass
Loss of muscle mass via Ultrasound of M. rectus femoris of a predefined leg
Measured: From date of randomization until the date of ICU discharge up to 1 month
Progress of urea / creatinine ratio
Urea / creatinine ratio in the patients´ blood
Measured: From date of randomization until the date of ICU discharge up to 1 month
Secondary outcomes (4)
Length of invasive and noninvasive ventilation
Length of invasive and noninvasive ventilation
Measured: From date of randomization until the date of ICU discharge up to 1 month
Length of ICU and hospital stay
Length of ICU and hospital stay
Measured: From date of randomization until the date of hospital discharge up to 6 months
30 day mortality on day 30
30 day mortality on day 30
Measured: From date of randomization 30 days
ICU mobility scale on discharge
ICU mobility scale (lowest score 0, highest score 10)
Measured: From date of randomization until the date of ICU discharge up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, randomized, interventional trial
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Emily Stoll, University Hospital of Cologne
- Investigators
- Bernd W Böttiger, Prof, Study director, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535815
- Sponsor's protocol ID
- 22-1398_1
- Acronym
- KetoNiFast
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.
- ClinicalTrials.gov ID
- NCT06535815
- Acronym / sponsor ID
- KetoNiFast / 22-1398_1
- Conditions
- Nutrition, Muscle Loss, Inflammatory Response
- Keywords
- Ketogenic diet, ketogenic fasting, cyclic enteral nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, prospective, randomized, interventional trial
| Arm | Type | Receives |
|---|---|---|
| Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting | Active comparator | Other: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Interventional group: 12 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. |
| Control: Conventional continuous enteral nutrition | No intervention | –Control group Continuous enteral nutrition for 24 hours (as per patients´ individual caloric requirements defined by indirect calorimetry). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent to participate in this study
- admission to ICU
- enteral nutrition
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)Also: cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation12 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. | Other | Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting |
Primary outcome
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
4 secondary outcomes
Length of invasive and noninvasive ventilation
Time frame: From date of randomization until the date of ICU discharge up to 1 month
Length of ICU and hospital stay
Time frame: From date of randomization until the date of hospital discharge up to 6 months
30 day mortality on day 30
Time frame: From date of randomization 30 days
ICU mobility scale on discharge
Time frame: From date of randomization until the date of ICU discharge up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd W Böttiger, Prof study director
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate) in people with Nutrition and Muscle Loss, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra E Stoll, MD, assProf. (+49221478 ext. 82054, sandraemilystoll@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of muscle mass (time frame: From date of randomization until the date of ICU discharge up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.