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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
20
The 12 hour feeding group will receive tube feeding only over a 12 hour period (6:00 AM to 6:00 PM feeding schedule).
Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.
University Of Kansas Health System
Kansas City, Kansas, United States
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.
Time frame: From randomization up to 10 days
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.
Time frame: From randomization up to 10 days
Sleep quantity
Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.
Time frame: 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
Time frame: From randomization up to 10 days
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