Time-Restricted Feeding for Critical Illness

Overseen By Felicia Steger, PhD, MS, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Comfort measures, GI surgery, Sedation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new feeding schedule for critically ill ICU patients. Researchers aim to determine if providing the same amount of nutrition over 12 hours (12-hour time-restricted feeding, or TRF12) is as effective as the usual 24-hour method. They examine how these schedules impact factors such as nutrient absorption and blood sugar levels. Adults in the ICU receiving continuous tube feedings may qualify for participation. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance ICU care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on feeding protocols for critically ill patients.

What prior data suggests that this time-restricted feeding protocol is safe for critically ill patients?

Research has shown that time-restricted feeding (TRF12) might be as safe as the usual 24-hour feeding schedule for critically ill patients. In TRF12, patients receive the same amount of nutrition over 12 hours instead of 24. Studies suggest that this method is generally well-tolerated. Patients on TRF12 did not experience more feeding-related issues than those on the 24-hour schedule. The goal is to provide necessary nutrition without causing additional health problems. Overall, both feeding schedules are expected to meet most patients' nutritional needs without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted feeding (TRF12) for critical illness because it offers a novel approach to nutrition delivery. Unlike the standard 24-hour continuous feeding (CONT24), which provides nutrition around the clock, TRF12 compresses the same nutritional intake into a 12-hour window by doubling the hourly feeding rate. This method could potentially improve metabolic outcomes and reduce complications associated with prolonged feeding periods. By aligning feeding times with the body's natural rhythms, TRF12 might enhance recovery and optimize energy utilization, promising a more efficient and potentially beneficial feeding strategy for critically ill patients.

What evidence suggests that this feeding protocol is effective for critically ill patients?

Research has shown that time-restricted feeding (TRF), which involves eating only during a set number of hours each day, can improve health. One study demonstrated that eating within a 10-hour window helped individuals with metabolic syndrome lose weight, lower blood pressure, and reduce unhealthy blood fats. Another study found that an 8-hour eating window led to significant weight loss in adults with obesity. Aligning feeding times with the body's natural rhythms might improve metabolism in critically ill patients. In this trial, participants will follow either a 12-hour TRF schedule or a continuous 24-hour feeding schedule. Current evidence indicates that both continuous and intermittent feeding schedules are equally safe for critically ill adults. These findings suggest that a 12-hour TRF schedule could be effective and safe for these patients. ^{3 4 5 6 7}

Who Is on the Research Team?

Felicia Steger, PhD, MS, RD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are critically ill and in an intensive care unit (ICU), with orders to receive continuous enteral nutrition. It's not specified who can't join, but typically those with conditions affecting feeding tolerance or at risk of adverse effects from changes in nutrition might be excluded.

Inclusion Criteria

I am currently in the ICU for a critical illness.

I am on a prescribed liquid feeding program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a 12-hour time-restricted feeding protocol or a 24-hour continuous feeding protocol

10 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mental health and quality of life assessments

3 months

Assessments at 1 month and 3 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• 12-hour time-restricted feeding (TRF12)

Trial Overview The study compares two feeding schedules for ICU patients: a 12-hour time-restricted feeding (TRF12) and a standard continuous 24-hour feeding (CONT24). The goal is to see if the TRF12 schedule is as safe and effective as CONT24 in providing necessary nutrition without causing additional health issues.

How Is the Trial Designed?

Group I: 12-hour time-restricted feeding (TRF12) Experimental Treatment 1 Intervention

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.

Group II: Continuous 24 hour feeding (CONT24). Active Control 1 Intervention

24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a study of 1353 older adults in Shanghai, time-restricted feeding (TRF) was linked to a higher incidence of cognitive impairment, suggesting that limiting eating to a shorter time window may negatively affect cognitive health.

TRF was found to be significantly associated with lower scores in cognitive functions such as 'Orientation to place' and 'Attention/calculation', indicating that restricting meal times could impair specific areas of cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. Li, J., Li, R., Lian, X., et al.[2023]

Time-restricted feeding (TRF) has been shown to reduce body weight and improve various metabolic disease risk factors, such as lowering cholesterol and glucose levels, based on both animal and human studies.

Human studies indicate that while TRF consistently lowers triglycerides and improves cholesterol profiles, the effects on body weight are not always consistent, suggesting further research is needed to fully understand its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. Rothschild, J., Hoddy, KK., Jambazian, P., et al.[2018]

In an 8-week study of time-restricted feeding (TRF) involving 32 women (13 premenopausal and 19 postmenopausal), both groups experienced similar weight loss of about 3.3% without any significant differences between them.

Both premenopausal and postmenopausal women showed reductions in fat mass, lean mass, fasting insulin, and oxidative stress markers, indicating that TRF can provide metabolic benefits regardless of menopausal status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2023]

A 4-week study on trained male endurance runners showed that a 16/8 time-restricted feeding (TRF) pattern led to a significant decrease in fat mass without affecting fat-free mass or running performance.

While the TRF group experienced lower carbon dioxide production and blood lactate levels during exercise, their 10 km time trial performance remained unchanged compared to those on a normal diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. Tovar, AP., Richardson, CE., Keim, NL., et al.[2021]

Time-restricted feeding (TRF) focuses on when meals are consumed rather than calorie content, showing potential benefits in rodent studies for preventing obesity and improving insulin sensitivity, which could translate to human health improvements.

Current evidence suggests that aligning eating windows with waking hours may optimize cardiometabolic health, particularly for individuals in high-stress jobs, although more human trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding for the prevention of cardiometabolic diseases in high-stress occupations: a mechanistic review. Waldman, HS., Renteria, LI., McAllister, MJ.[2020]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a study of 49 adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) led to significant weight loss (around 3.4 to 3.9 kg) over 8 weeks, but did not improve sleep quality or duration compared to a control group.

Neither 4-hour nor 6-hour TRF affected insomnia severity or the risk of obstructive sleep apnea, indicating that while TRF can aid in weight loss, it may not enhance sleep-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of 4-h versus 6-h time restricted feeding on sleep quality, duration, insomnia severity and obstructive sleep apnea in adults with obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357572/

Advances in Intermittent Fasting Applications for Critically ... Ten-hour time-restricted eating reduces weight, blood pressure, and atherogenic lipids in patients with metabolic syndrome. Cell Metab. 2020 ...

2. withpower.com withpower.com/trial/phase-critical-illness-2025-2610b

Time-Restricted Feeding for Critical Illness In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating ...

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-04994-0

Feeding critically ill patients at the right time of day - Critical Care Supporting the circadian health of critically ill patients through modern feeding schedules has the potential to improve metabolic outcomes by ...

4. researchgate.net researchgate.net/publication/394460108_Advances_in_Intermittent_Fasting_Applications_for_Critically_Ill_Patients

Advances in Intermittent Fasting Applications for Critically ... Summary Current evidence suggests comparable safety profiles for continuous and intermittent feeding schedules in critically ill adult patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9165551/

Time-Restricted Feeding Studies and Possible Human Benefit Preclinical studies demonstrate that restricting the time during a 24-hour period when an obese animal eats (time-restricted feeding) leads to metabolic ...

6. clinicaltrials.gov clinicaltrials.gov/study/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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12425950/

Daytime only or time restricted feeding in critically ill patients The overnight fasting times ranged from 6 to 12 h, with reported primary outcomes of feed intolerance, nutritional delivery, ketosis ...