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

Trial Summary

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 data supports the effectiveness of the 12-hour time-restricted feeding (TRF12) treatment for critical illness?

Research on time-restricted feeding (TRF) shows it can help reduce body weight and improve metabolic health markers like cholesterol and blood sugar levels in both animals and humans. These findings suggest that TRF might be beneficial for managing metabolic health, which could be relevant for critical illness. ^{1 2 3 4 5}

Is time-restricted feeding generally safe for humans?

Time-restricted feeding (TRF) has been studied in various contexts, and while it shows potential health benefits, there are some concerns. In older adults, TRF may be linked to cognitive impairment, but more research is needed to fully understand its safety and effects on human health. ^{3 4 6 7 8}

How does the 12-hour time-restricted feeding treatment differ from other treatments for critical illness?

The 12-hour time-restricted feeding (TRF12) treatment is unique because it involves limiting eating to a specific 12-hour window each day, which is a form of intermittent fasting. This approach is different from traditional treatments for critical illness that may not focus on meal timing and instead emphasize continuous nutrition or specific dietary components. ^{3 4 5 6 9}

What is the purpose of this trial?

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.

Research Team

Felicia Steger, PhD, MS, RD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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) 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early time-restricted feeding improves high-density lipoprotein amount and function in nonhuman primates, without effects on body composition. [2023]

5. England 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. [2022]

6. Switzerland 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Time-restricted feeding for the prevention of cardiometabolic diseases in high-stress occupations: a mechanistic review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]