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

Trial Summary

What is the purpose of this trial?

Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk. The study will evaluate if restricted eating duration (8 hours/day) could improve cardiovascular and metabolic health in habitual short sleepers.

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 data supports the effectiveness of the treatment Time Restricted Eating (TRE) for sleep deprivation?

Research suggests that Time Restricted Eating (TRE) may improve sleep and health-related quality of life, as well as help with weight loss and cardiovascular health. While these studies focus on other conditions, they indicate potential benefits of TRE that could also positively impact sleep. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in humans and is generally considered safe, with research showing it can lead to weight loss and metabolic benefits without altering diet quality. However, individual responses can vary, and it's important to consult with a healthcare provider before starting any new dietary regimen. ^{1 2 4 6 7}

How is time-restricted eating different from other treatments for sleep deprivation?

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, rather than what you eat. This approach is different from other treatments for sleep deprivation, which might focus on sleep hygiene or medication, as it potentially influences sleep patterns by regulating eating times. ^{1 4 6 8 9}

Research Team

Prachi Singh, PhD

Principal Investigator

Pennington Biomedical Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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) 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]

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), 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]

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) 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]

References

1. Switzerland 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. [2023]

2. 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]

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

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

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

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

5. England 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. [2020]

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

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

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

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

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

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

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

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. [2023]