12-hour Time Limited Feeding in Critical Care

NCT ID: NCT06741761

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Continuous 24 hour feeding (CONT24).

24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.

Group Type ACTIVE_COMPARATOR

Continuous 24 hour feeding (CONT24).

Intervention Type OTHER

Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.

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.

Group Type EXPERIMENTAL

12-hour time-restricted feeding (TRF12)

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Continuous 24 hour feeding (CONT24).

Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* "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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Felicia Steger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felicia Steger, PhD, MS, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University Of Kansas Health System

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Felicia Steger, PhD, MS, RD

Role: CONTACT

913-945-5822

Annie Henderson, RD

Role: CONTACT

913-735-5411

Facility Contacts

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Felicia Steger, PhD

Role: primary

Other Identifiers

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00161009

Identifier Type: -

Identifier Source: org_study_id

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