12-hour Time Limited Feeding in Critical Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Other: Continuous 24 hour feeding (CONT24).; Other: 12-hour time-restricted feeding (TRF12)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous 24 hour feeding (CONT24).; 24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.	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.
Experimental: 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.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization up to 10 days
Sleep quantity	Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.	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	From randomization up to 10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive health	National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) will be used to assess depression or anxiety as a T-score two standard deviations above the mean. A higher score in each category indicates more of the concept being measured.	From 1 month and 3 months post-discharge
Mental health	Mental health will be measured using the Personal Health Questionnaire-9 (PHQ-9). To provide a numerical score, we will assess anxiety, depression, and post-traumatic stress syndrome. The total score ranges from 0 to 27, with higher scores indicating more severe anxiety, depression and post-traumatic stress syndrome.	From 1 month and 3 months post-discharge
Impact of Health Status on Quality of life	Investigators will use the Health-Related Quality of Life survey to provide a measure of the impact of health status on quality of life.	From 1 month and 3 months post-discharge

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Felicia Steger, PhD, MS, RD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): March 4, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: enteral feeding; intermittent fasting; critical illness; time-restricted feeding
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Fasting; Critical Illness; Intermittent Fasting
• Other Study ID Numbers: 00161009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No