12-hour Time Limited Feeding in Critical Care

NCT06741761 | Active Not Recruiting DMC

• 1 other identifier: 00161009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

time-restricted feeding; enteral feeding; critical illness; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Glycemic control

  From randomization up to 10 days

• Sleep quantity

  From randomization up to 10 days

• Circadian rhythm of skin surface temperature

  From randomization up to 10 days

Other Outcomes (3)

• Mental health

  From 1 month and 3 months post-discharge

• Cognitive health

  From 1 month and 3 months post-discharge

• Impact of Health Status on Quality of life

  From 1 month and 3 months post-discharge

Study Arms (2)

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.

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.

Other: 12-hour time-restricted feeding (TRF12)

Interventions

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).

12-hour time-restricted feeding (TRF12)

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.

Continuous 24 hour feeding (CONT24).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• "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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University Of Kansas Health System

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Critical Illness; Intermittent Fasting

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Felicia Steger, PhD, MS, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 19, 2024
• Study Start: March 25, 2025
• Primary Completion: March 4, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)