Time-Restricted Eating for Shift Work Sleep Disorder

(SHINE Trial)

Overseen By Ellen Lyon, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Sleep disorders, Eating disorders, Diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 2

50 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's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Time-Restricted Eating for Shift Work Sleep Disorder?

Research on time-restricted eating (TRE) shows it can have positive effects on body weight and metabolic health in animal studies, but results in humans are mixed. Some studies suggest that TRE might improve sleep quality, but more research is needed to confirm its effectiveness for shift work sleep disorder. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in humans and shows promising health benefits without compromising physical performance. However, more research is needed to fully understand its safety, especially in shift workers. ^{4 6 7 8 9}

How is time-restricted eating different from other treatments for shift work sleep disorder?

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, aligning with your body's natural circadian rhythms (internal body clock), which may help improve sleep patterns. Unlike other treatments that might involve medication or lifestyle changes, TRE is a simple dietary approach that doesn't require calorie counting or specific food restrictions. ^{1 2 5 8 10}

What is the purpose of this trial?

People who experience repeated bouts of circadian misalignment, such as shift workers, are at higher risk of cardiovascular disease (CVD) and Type 2 diabetes (T2D) compared to daytime workers. However, the mechanism(s) by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown. This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function, insulin sensitivity, glucose homeostasis and muscle lipid accumulation, which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment, which includes more than 20% of the US workforce.

Research Team

Josiane L Broussard, PhD

Principal Investigator

Colorado State University

Eligibility Criteria

This trial is for chronic night shift workers who may have sleep and circadian rhythm disorders, insulin sensitivity or resistance issues, metabolic diseases, high blood pressure but not severe allergies.

Inclusion Criteria

Worked the night shift for the last 1 year or more

Habitually sleep 5-9 hours per 24h period

Body mass index (BMI) of 20.0 - 35.0 kg/m2 and weight stable (plus or minus 5% of current body weight in the last 6 months)

Exclusion Criteria

I have been following a special diet like keto or vegan that could affect my cholesterol levels.

I have a diagnosed sleep or eating disorder.

Following any TRE (time-restricted eating) or intermittent fasting plan in the last year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Time-restricted eating (TRE)

Participants follow a time-restricted eating schedule during overnight work shifts for 4 weeks, refraining from eating during the biological night while maintaining the same sleep opportunity and daily energy intake.

4 weeks

1 visit (inpatient) at the end of 4 weeks

Washout

Participants undergo a 4-week washout period between treatment conditions.

4 weeks

Treatment - Control

Participants eat during the biological night as typically done in night shift workers for 4 weeks.

4 weeks

1 visit (inpatient) at the end of 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• Control eating
• Time-restricted eating

Trial Overview The study investigates if eating within a set time frame (time-restricted eating) versus regular eating patterns (control eating) affects heart health and sugar metabolism in people with disrupted body clocks due to shift work.

Participant Groups

Group I: Time-restricted eating during overnight work shift Experimental Treatment 1 Intervention

For 4 weeks, participants will refrain from eating during the biological night while maintaining the same sleep opportunity and daily energy intake and macronutrient distribution without changing 24h energy intake.

Group II: Control eating during overnight work shift Experimental Treatment 1 Intervention

For 4 weeks, participants will eat during the biological night as is typically done in night shift workers.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Findings from Research

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]

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 study of 23 obese adults following an 8-hour time-restricted feeding (TRF) schedule for 12 weeks, sleep quality remained consistently good, as indicated by a Pittsburgh Sleep Quality Index score below 5 throughout the trial.

The research found that TRF did not change subjective measures of sleep duration or timing, suggesting that this dietary approach does not negatively impact sleep in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. Gabel, K., Hoddy, KK., Burgess, HJ., et al.[2020]

In a study involving 24 healthy males living in a sleep laboratory for 12 days, those experiencing severe sleep restriction (4 hours of sleep) consumed significantly more snacks, especially sweet snacks, compared to those with moderate sleep restriction (6 hours of sleep).

The findings suggest that severe sleep restriction may increase the risk of obesity and related health issues among shiftworkers due to higher snack consumption and a preference for unhealthy snack choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep restriction on snacking behaviour during a week of simulated shiftwork. Heath, G., Roach, GD., Dorrian, J., et al.[2022]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., 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]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

The Healthy Heroes Study is a year-long randomized controlled trial involving 150 firefighters, investigating the effects of a 10-hour time-restricted eating (TRE) regimen on health parameters related to cardiometabolic disease risks.

The study aims to assess the feasibility and efficacy of TRE compared to standard Mediterranean diet counseling, monitoring various health metrics such as blood glucose, body weight, and biomarkers, to determine if TRE can help mitigate health risks associated with chronic circadian rhythm disruption in firefighters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study. Manoogian, ENC., Zadourian, A., Lo, HC., et al.[2021]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Canada pubmed.ncbi.nlm.nih.gov

Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The effect of sleep restriction on snacking behaviour during a week of simulated shiftwork. [2022]

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

Complex physiology and clinical implications of time-restricted eating. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]

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

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

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

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

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

Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study. [2021]

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]