12-hour Time Limited Feeding in Critical Care

Not Applicable

Recruiting

• Conditions: Critical Illness

• Registration Number: NCT06741761
• Lead Sponsor: University of Kansas Medical Center

Brief 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. 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 Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-17
• Status Verified: 2025-03
• Study Start: 2025-03-25
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and feasibility	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.

Secondary Outcome Measures

Name	Time	Method
Glycemic control	From randomization up to 10 days	Glycemic control will be assessed using a continuous glucose monitor to measure time-in-range (%), time-above-range, and number of hypoglycemic events.
Sleep quantity	From randomization up to 10 days	Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.
Circadian rhythm of skin surface temperature	From randomization up to 10 days	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

Trial Locations

Locations (1)

University Of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States