Critical IllnessNCT06741761
12-hour Time Limited Feeding in Critical Care
A study testing 12-hour time-restricted feeding (TRF12) and Continuous 24 hour feeding (CONT24). in people with Critical Illness, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- 12-hour time-restricted feeding (TRF12) and Continuous 24 hour feeding (CONT24).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (≥18 years of age)
- With critical illness (hospitalized in an intensive care unit with a status of "ICU")
- Who have received orders for continuous enteral nutrition
Who cannot join
- "Comfort Measures Only" status
- Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
- Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
- Receiving continuous sedation
- Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
- History of malabsorptive bariatric surgery
Show all 14Show fewer
- Admitted for a burn injury
- Known intolerance to feeding rates >100mL/hr
- Current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube)
- Requiring intermittent or continuous renal replacement therapy
- Pregnant or lactating
- On an intermittent feeding schedule
- Nutritional needs would require a rate higher than 120mL/hr on TRF12 protocol
- Lack of clearance by primary physician
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kansas Health System
Kansas City, Kansas, 66103
About this study
Official title: The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults
This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients.
- Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding.
- Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.
Read the detailed description
Investigators will test a 12-hour time-restricted feeding (TRF12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (CONT24) schedule. Time-restricted feeding (TRF) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. TRF may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. In critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. In addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.
- Conditions
- Critical Illness
- Being tested
- 12-hour time-restricted feeding (TRF12), Continuous 24 hour feeding (CONT24).
- Keywords
- time-restricted feeding, enteral feeding, critical illness, intermittent fasting
- Medical subject headings
- Critical Illness, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-hour time-restricted feeding (TRF12)Other
The 12 hour feeding group will receive tube feeding only over a 12 hour period (6:00 AM to 6:00 PM feeding schedule).
Continuous 24 hour feeding (CONT24).Other
Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Continuous 24 hour feeding (CONT24). | Active comparator | 24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily. Receives: Other: Continuous 24 hour feeding (CONT24). |
| 12-hour time-restricted feeding (TRF12) | Experimental | The 12-hour time-restricted feeding group will receive the same amount of nutrition in 12 hours as would be needed in 24 hours. The hourly feeding rate will double. Receives: Other: 12-hour time-restricted feeding (TRF12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility
Safety will be measured by the need for pausing or discontinuing enteral feeds, gastrointestinal complications (including vomiting, abdominal distention, and diarrhea), other feeding complications (e.g., aspiration, gastric residuals), and hypoglycemic events. Feasibility is defined as the percentage of patients who received ≥75% of their prescribed nutrition goal, and the logistical feasibility of collecting study data.
Measured: From randomization up to 10 days
Secondary outcomes (3)
Glycemic control
Glycemic control will be assessed using a continuous glucose monitor to measure time-in-range (%), time-above-range, and number of hypoglycemic events.
Measured: From randomization up to 10 days
Sleep quantity
Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.
Measured: From randomization up to 10 days
Circadian rhythm of skin surface temperature
Circadian rhythm of skin surface temperature will be measured across 24-hours and the phase and amplitude of the circadian rhythm of skin temperature will be quantified
Measured: From randomization up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start25 Mar 2025
- Primary completion4 Mar 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicia Steger, University of Kansas Medical Center
- Investigators
- Felicia Steger, PhD, MS, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741761
- Sponsor's protocol ID
- 00161009
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT06741761
- Acronym / sponsor ID
- 00161009
- Conditions
- Critical Illness
- Keywords
- time-restricted feeding, enteral feeding, critical illness, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Dec 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.
This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients.
- Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding.
- Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.
Detailed description
Investigators will test a 12-hour time-restricted feeding (TRF12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (CONT24) schedule. Time-restricted feeding (TRF) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. TRF may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. In critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. In addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous 24 hour feeding (CONT24). | Active comparator | Other: Continuous 24 hour feeding (CONT24).24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily. |
| 12-hour time-restricted feeding (TRF12) | Experimental | Other: 12-hour time-restricted feeding (TRF12)The 12-hour time-restricted feeding group will receive the same amount of nutrition in 12 hours as would be needed in 24 hours. The hourly feeding rate will double. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years of age)
- With critical illness (hospitalized in an intensive care unit with a status of "ICU")
- Who have received orders for continuous enteral nutrition
Key exclusion criteria (14 listed)
- "Comfort Measures Only" status
- Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
- Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
- Receiving continuous sedation
- Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
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 |
|---|---|---|
| 12-hour time-restricted feeding (TRF12)The 12 hour feeding group will receive tube feeding only over a 12 hour period (6:00 AM to 6:00 PM feeding schedule). | Other | 12-hour time-restricted feeding (TRF12) |
| Continuous 24 hour feeding (CONT24).Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours. | Other | Continuous 24 hour feeding (CONT24). |
Primary outcome
Safety and feasibility
Time frame: From randomization up to 10 days
Safety will be measured by the need for pausing or discontinuing enteral feeds, gastrointestinal complications (including vomiting, abdominal distention, and diarrhea), other feeding complications (e.g., aspiration, gastric residuals), and hypoglycemic events. Feasibility is defined as the percentage of patients who received ≥75% of their prescribed nutrition goal, and the logistical feasibility of collecting study data.
3 secondary outcomes
Glycemic control
Time frame: From randomization up to 10 days
Sleep quantity
Time frame: From randomization up to 10 days
Circadian rhythm of skin surface temperature
Time frame: From randomization up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Felicia Steger, PhD, MS, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-hour time-restricted feeding (TRF12) and Continuous 24 hour feeding (CONT24). in people with Critical Illness, run by University of Kansas Medical Center at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility (time frame: From randomization up to 10 days). 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 28 Apr 2026.