Time Restricted Eating for Sleep Deprivation

(CRISP Trial)

Overseen By Prachi Singh, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Sleep disorders, Depression, Anxiety, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether limiting eating to an 8-hour window each day, known as Time Restricted Eating (TRE), can improve heart and metabolic health in people who don't sleep much. Researchers aim to determine if constant eating contributes to higher risks like high blood pressure and poor glucose control in those who sleep 6.5 hours or less each night. Participants will either follow this 8-hour eating window or continue their usual eating habits. This trial suits those who typically eat over a 14-hour period daily, sleep less than 6.5 hours a night, and have no chronic health conditions. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on lifestyle changes and health.

Will I have to stop taking my current medications?

The trial allows the use of certain medications like birth control, second-generation antihistamines, antacids, and acne-related ointments. However, if you are taking medications for chronic conditions like high blood pressure, high cholesterol, or diabetes, you may not be eligible to participate. It's best to discuss your specific medications with the study team.

What prior data suggests that time restricted eating is safe for improving cardiovascular and metabolic health?

Research has shown that time-restricted eating (TRE) is generally safe for most people. Studies have found that TRE does not negatively affect sleep, mood, or overall quality of life. In fact, it can aid in weight loss, improve body health, and lower blood pressure, all of which benefit heart health.

One study found that eating within an 8-hour period did not affect sleep quality in young people with obesity, suggesting that TRE can be suitable for different age groups.

Overall, TRE appears to be a safe way to enhance health without causing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for sleep deprivation because it offers a non-invasive approach that focuses on when you eat, rather than what you eat. Unlike traditional treatments for sleep issues, which may involve medication or therapy, TRE simply limits eating to an 8-hour window each day, potentially aligning better with our natural body clocks. This method could help improve sleep quality by synchronizing meal times with the body's circadian rhythms, without the need for drugs or significant lifestyle changes.

What evidence suggests that time restricted eating could be effective for improving cardiovascular and metabolic health in short sleepers?

This trial will compare time-restricted eating (TRE) with habitual eating duration. Research has shown that TRE, which involves eating only during an 8-hour period each day, might improve the health of people who don't get enough sleep. Some studies suggest TRE could aid in weight loss and reduce body fat. While the effectiveness of TRE in managing blood sugar remains unclear, aligning eating with the body's natural rhythm might be beneficial. Importantly, TRE does not appear to harm sleep quality, mood, or overall quality of life. Overall, TRE shows promise for improving the health of those who sleep less, but more research is needed to fully understand its benefits. ^{1 6 7 8 9}

Who Is on the Research Team?

Prachi Singh, PhD

Principal Investigator

Pennington Biomedical Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 with a BMI of 25-35 who usually sleep less than 6.5 hours and eat over a span of more than 14 hours per day. They should not have chronic health issues like hypertension or diabetes, but those with prehypertension or prediabetes may join if they agree to use birth control (if applicable) and can follow the study's eating schedule.

Inclusion Criteria

Women of child-bearing age if they agree to use acceptable birth control

I do not have chronic conditions like high blood pressure, high cholesterol, diabetes, or heart disease, except for early signs of high blood pressure or sugar.

I am currently using medications like birth control, antihistamines, antacids, or acne ointments.

Exclusion Criteria

You have donated blood or plasma in the last 2 months.

I often feel very sleepy during the day.

I have lost or gained more than 5% of my body weight in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either time restricted eating (8h/day) or habitual eating duration (>14h/day) for 4 weeks

4 weeks

Follow-up

Participants are monitored for changes in cardiovascular and metabolic markers after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time restricted eating (TRE)

Trial Overview The study tests whether limiting eating to an 8-hour window each day can improve heart health and blood sugar levels in people who don't get much sleep. Participants will maintain their normal diet, sleep, and exercise routines while following this time-restricted eating plan.

How Is the Trial Designed?

Group I: Time restricted eating (TRE) Experimental Treatment 1 Intervention

Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.

Group II: Habitual eating duration Active Control 1 Intervention

Subjects randomized to this arm will be asked to continue habitual eating duration of \>14h/day for 4 weeks.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

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]

Time-restricted eating (TRE) for 3 months led to significant improvements in health-related quality of life (HRQoL) and sleep quality among 99 participants, regardless of weight loss, indicating its potential as a beneficial lifestyle change.

The study found that the duration of fasting and baseline sleep quality were key factors influencing improvements in HRQoL, suggesting that TRE can enhance well-being without requiring medical supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of time-restricted eating with health-related quality of life and sleep in adults: a secondary analysis of two pre-post pilot studies. Kesztyüs, D., Fuchs, M., Cermak, P., et al.[2020]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

In a 12-week study with 20 participants, time-restricted eating (TRE) led to significant changes in meal timing, including delaying the first meal by nearly 3 hours and advancing the last meal by over 1 hour, which may contribute to weight loss and improved health outcomes.

The TRE group also significantly reduced late-night eating by 14%, with 63% of participants completely eliminating late-night eating, and this was associated with longer sleep duration, suggesting that TRE may improve overall eating patterns and sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a self-selected time restricted eating intervention on eating patterns, sleep, and late-night eating in individuals with obesity. Simon, SL., Blankenship, J., Manoogian, ENC., 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]

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]

Time-restricted eating (TRE) shows potential for lowering blood pressure in adults with metabolic syndrome, particularly when meals are consumed earlier in the day and within narrower eating windows.

Current studies on TRE and blood pressure outcomes are limited and inconsistent, highlighting the need for more research to explore the effects of TRE on blood pressure variability throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. Duan, D., Bhat, S., Jun, JC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322763/

The effects of time-restricted eating on sleep in adults Current evidence indicates that short to mid-term TRE does not typically worsen sleep parameters. However, some populations may experience reduced sleep ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835594

Time-Restricted Eating and Sleep, Mood, and Quality of ... We found that TRE, irrespective of the eating window timing, was not associated with adverse effects on sleep, mood, or quality of life in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1087079225001467

The effects of intermittent fasting on sleep quality and ... No overall effects of IF on sleep relative to ad libitum eating were observed, despite improvements in weight. This analysis supports IF ...

4. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/1264/8116999

Effect of Time-Restricted Eating on Sleep Quality and Body ... Time-restricted eating seems to be effective in weight loss and fat mass reduction, but most studies found no effect on sleep parameters.

5. mdpi.com mdpi.com/2072-6643/17/10/1689

The Effectiveness of Time-Restricted Eating as an ... Time-restricted eating (TRE) could improve glucose metabolism by aligning food intake with the circadian clock, but its effectiveness remains unclear.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6953486/

Ten-hour time-restricted eating reduces weight, blood ... Time-restricted eating led to weight loss, healthier body composition, lower blood pressure, and decreased levels of cardiovascular disease-promoting lipids.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity In participants with obesity, time-restricted eating results in 3%–5% weight loss over 2–12 months, versus controls. Reductions in body weight ...

8. academic.oup.com academic.oup.com/edrv/article/43/2/405/6371193

Time-restricted Eating for the Prevention and Management of ... Pilot human intervention studies have reported promising results in reducing the risk for obesity, diabetes, and cardiovascular diseases. Epidemiological ...

9. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10734

Impact of 8-hour time-limited eating on sleep in adolescents ... The results highlight that 8-hour time-limited eating does not negatively impact sleep in youth with obesity when compared to a prolonged eating window.