Time Restricted Eating for Sleep Deprivation
(CRISP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Pennington Biomedical Research Center
Disqualifiers: Sleep disorders, Depression, Anxiety, others
No Placebo Group
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.
12345Is 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.
12467How 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.
14689Eligibility 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.
+7 more
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.
+7 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eating (TRE)Experimental Treatment1 Intervention
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.
Group II: Habitual eating durationActive Control1 Intervention
Subjects randomized to this arm will be asked to continue habitual eating duration of \>14h/day for 4 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Recruiting core PenningtonBaton Rouge, LA
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Who Is Running the Clinical Trial?
Pennington Biomedical Research CenterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
The impact of a self-selected time restricted eating intervention on eating patterns, sleep, and late-night eating in individuals with obesity. [2023]Time restricted eating (TRE), limiting eating to a specific daily window, is a novel dietary intervention, but the mechanisms by which TRE results in weight loss remain unclear. The goal of the current study was to examine changes in eating patterns, sleep, and late-night eating, and associations with health outcomes in a secondary analysis of a 12-week self-selected TRE intervention.
Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose.
Complex physiology and clinical implications of time-restricted eating. [2023]Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and physiological functions has been extensively studied in rodent models, which have shown considerable therapeutic effects of TRE and important interactions among time of eating, circadian biology, and metabolic homeostasis. In contrast, it is difficult to make firm conclusions regarding the effect of TRE in people because of the heterogeneity in results, TRE regimens, and study populations. In this review, we 1) provide a background of the history of meal consumption in people and the normal physiology of eating and fasting; 2) discuss the interaction between circadian molecular metabolism and TRE; 3) integrate the results of preclinical and clinical studies that evaluated the effects of TRE on body weight and physiological functions; 4) summarize other time-related dietary interventions that have been studied in people; and 4) identify current gaps in knowledge and provide a framework for future research directions.
Time-Restricted Eating to Improve Cardiovascular Health. [2021]Time-restricted eating (TRE) is a form of intermittent fasting that involves confining the eating window to 4-10 h and fasting for the remaining hours of the day. The purpose of this review is to summarize the current literature pertaining to the effects of TRE on body weight and cardiovascular disease risk factors.
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]Therapeutic fasting may improve health-related quality of life (HRQoL) and sleep but is not applicable for everyone. Time-restricted eating (TRE) offers a low threshold alternative but research on associations with HRQoL and sleep is rare.
Time restricted eating as a weight loss intervention in adults with obesity. [2021]Time-restricted eating (TRE) is a weight management approach in which food is consumed only within a specific period each day. The simplicity of this approach is appealing, but its efficacy is not known. The aim of this pilot cohort study was to assess adherence to TRE and its effects on weight and lipid profile.
Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]Eating out of phase with the biological clock induces circadian misalignment in peripheral organs and impairs glucose tolerance in preclinical models. Time-restricted eating (TRE) is a dietary approach that consolidates energy intake to 6 to 10 hours during the biologically active phase of the day, without necessarily altering diet quality and quantity. TRE induces pleiotropic metabolic benefits in mice, flies, and humans. Most studies have initiated TRE early in the biological morning. This perspective discusses the potential challenges in translating early TRE to the community and considers the potential metabolic consequences of delaying TRE.
Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]Time-restricted eating (TRE), which restricts food intake to a limited duration of the day, is a key regimen of intermittent fasting.
Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. [2023]Time-restricted eating (TRE) is a promising dietary intervention for weight loss and improvement of cardiometabolic risk factors. We aim to provide a critical review of blood pressure outcomes reported in clinical TRE studies in adults with metabolic syndrome, in the context of the proposed mechanisms that underlie the relationship between timing of eating and blood pressure.