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Active, Not Recruiting

NCT Number: NCT06741761

12-hour Time Limited Feeding in Critical Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Critical Illness Behavior Disease Attributes Fasting Feeding Behavior Intermittent Fasting Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kansas Health System

Kansas City, Kansas, 66103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Glycemic control

    Time frame: 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.

  2. Sleep quantity

    Time frame: From randomization up to 10 days

    Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.

  3. Circadian rhythm of skin surface temperature

    Time frame: 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

Other outcomes

  1. Mental health

    Time frame: From 1 month and 3 months post-discharge

    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.

  2. Cognitive health

    Time frame: From 1 month and 3 months post-discharge

    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.

  3. Impact of Health Status on Quality of life

    Time frame: From 1 month and 3 months post-discharge

    Investigators will use the Health-Related Quality of Life survey to provide a measure of the impact of health status on quality of life.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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