Meal Timing and Sleep for Metabolic Health in Healthy Subjects
(DT2 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Sedatives, Anxiolytics, Opiates, others
Disqualifiers: Sleep disorders, Diabetes, Kidney disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study examines the acute impact of eating an "early" versus "late" dinner. "Early" and "late" will be customized to individuals based on the individuals' own circadian rhythms. Healthy adults will have the adults' circadian rhythm assessed by measuring the adults' dim light melatonin onset (DLMO). Based on the timing of DLMO, participants will be randomized to eating dinner before DLMO or after DLMO. The investigators will also compare the effects of delaying sleep relative to dinner time. Participants will eat meals in the laboratory and have serial plasma samples collected to examine profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.
Will I have to stop taking my current medications?
The trial requires that you do not use medications that can affect circadian rhythm, such as beta blockers and melatonin. If you are taking these, you would need to stop before participating.
What data supports the effectiveness of the treatment involving meal timing and sleep for metabolic health?
Research suggests that eating earlier in the day and aligning meal times with natural body rhythms can help improve metabolic health and prevent obesity. Studies show that having dinner earlier, especially several hours before sleep, is linked to better weight management and metabolic function.
12345Is meal timing generally safe for humans?
Research on meal timing, such as having dinner earlier or later, has primarily focused on its effects on sleep and metabolic health rather than safety concerns. No specific safety issues have been reported in studies involving healthy volunteers, suggesting that adjusting dinner timing is generally safe for humans.
12678How does the treatment of meal timing and sleep differ from other treatments for metabolic health?
This treatment is unique because it focuses on aligning meal timing with the body's natural circadian rhythms (internal body clocks) to improve metabolic health, rather than relying on medications or supplements. By adjusting when meals are consumed in relation to sleep, it aims to optimize metabolic processes and prevent disorders, which is a novel approach compared to traditional treatments.
127910Eligibility Criteria
This trial is for healthy adults aged 18-30, with a BMI of 18-30 kg/m2 and normal sleep patterns (bedtime before 1:00 A.M. and mid-sleep before 5 A.M.). Participants should not be smokers or have conditions like diabetes, sleep disorders, GERD that affects eating near bedtime, or use medications affecting circadian rhythms.Inclusion Criteria
Accustomed to a bedtime before 1:00 A.M. or having mid-sleep on free days (MSF) earlier than 5 A.M. from the Munich Chronotype Questionnaire (MCTQ) (to exclude extreme late chronotypes)
I regularly use medications for anxiety, sleep, or pain.
Your body mass index (BMI) falls between 18 and 30.
+6 more
Exclusion Criteria
I have severe heartburn that prevents me from eating late.
DLMO > 24:00 will be excluded from the metabolic study visits
I have a history of an inherited metabolic disorder.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 3-arm randomized crossover study to assess the metabolic impact of early and late dinner times relative to DLMO, with serial blood sampling and sleep studies
8 weeks
3 visits (in-person), each lasting 25 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study investigates how the timing of dinner relative to one's own circadian rhythm impacts metabolism. It involves having an early or late dinner based on melatonin onset measurements and observing changes in metabolic markers like glucose and insulin levels.
3Treatment groups
Experimental Treatment
Group I: Late Dinner firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.
Group II: Late Dinner + Late Sleep firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by delayed bedtime (DLMO+6h). This arm will cross-over to the other 2 arms in random order.
Group III: Early Dinner firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at an early dinner time (DLMO-3h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
Johns Hopkins Bayview Medical CenterBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
National Cancer Institute (NCI)Collaborator
National Marrow Donor ProgramCollaborator
University of ArkansasCollaborator
References
The Elapsed Time between Dinner and the Midpoint of Sleep is Associated with Adiposity in Young Women. [2020]Meal timing relative to sleep/wake schedules is relevant in the search for obesity risk factors. However, clock time does not accurately characterize the timing of food intake in the context of internal circadian timing. Therefore, we studied elapsed between dinner and the midpoint of sleep (TDM) as a practical approach to evaluate meal timing relative to internal timing, and its implications on obesity. To do so, adiposity, sleep, diet, physical activity, and TDM were measured in 133 women. The participants were grouped into four categories according to their sleep timing behavior (early-bed/early-rise; early-bed/late-rise; late-bed/early-rise; late-bed/late-rise). Differences among the categories were tested using ANOVA, while restricted cubic splines were calculated to study the association between TDM and adiposity. Our results show that, although participants had dinner at about the same time, those that had the shortest TDM (early-bed/early-rise group) were found to have significantly higher BMI and waist circumference values (2.3 kg/m2 and 5.2 cm) than the other groups. In addition, a TDM of 6 h was associated with the lowest values of adiposity. The TDM could be a practical approach to personalizing meal timing based on individual sleep/wake schedules. Thus, according to our findings, dining 6 h before the midpoint of sleep is an important finding and could be vital for future nutritional recommendations and for obesity prevention and treatment.
Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. [2022]Eating time and sleep habits are important modifiable behaviors that affect metabolic health, but the relationship between food intake and sleep remains incompletely understood. Observational data suggest that late food intake is associated with impaired sleep quality. We examined the effect of routine dinner (RD, 5 hours before bedtime) vs late dinner (LD, 1 hour before bedtime) on sleep architecture in healthy volunteers.
Timing of food intake: Sounding the alarm about metabolic impairments? A systematic review. [2018]Growing evidence points to an association between timing of food intake and obesity in humans, raising the question if when to eat matters as much as what and how much to eat. Based on the new definition of obesity as a chronobiological disease, an unusual or late meal timing represent a circadian chronodisruption, leading to metabolic impairments. Preliminary data from cross-sectional and experimental studies suggest that changes in meal timing can influence obesity and success of weight loss therapy, independently from total energy intake, dietary composition and estimated energy expenditure. A systematic review of observational and experimental studies in humans was conducted to explore the link between time of food ingestion, obesity and metabolic alterations. Results confirm that eating time is relevant for obesity and metabolism: observational and experimental studies found an association between meal timing, weight gain, hyperglycemia and diabetes mellitus with benefits deriving from an early intake of food in the day in a wide range of individuals. Herein clinical, future perspectives of chronoprevention and chronotherapy of obesity and type 2 diabetes are also provided. In conclusion, meal timing appears as a new potential target in weight control strategies, and therapeutic strategies should consider this contributor in the prevention of obesity.
Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. [2021]The circadian timing system governs daily biological rhythms, synchronising physiology and behaviour to the temporal world. External time cues, including the light-dark cycle and timing of food intake, provide daily signals for entrainment of the central, master circadian clock in the hypothalamic suprachiasmatic nuclei (SCN), and of metabolic rhythms in peripheral tissues, respectively. Chrono-nutrition is an emerging field building on the relationship between temporal eating patterns, circadian rhythms, and metabolic health. Evidence from both animal and human research demonstrates adverse metabolic consequences of circadian disruption. Conversely, a growing body of evidence indicates that aligning food intake to periods of the day when circadian rhythms in metabolic processes are optimised for nutrition may be effective for improving metabolic health. Circadian rhythms in glucose and lipid homeostasis, insulin responsiveness and sensitivity, energy expenditure, and postprandial metabolism, may favour eating patterns characterised by earlier temporal distribution of energy. This review details the molecular basis for metabolic clocks, the regulation of feeding behaviour, and the evidence for meal timing as an entraining signal for the circadian system in animal models. The epidemiology of temporal eating patterns in humans is examined, together with evidence from human intervention studies investigating the metabolic effects of morning compared to evening energy intake, and emerging chrono-nutrition interventions such as time-restricted feeding. Chrono-nutrition may have therapeutic application for individuals with and at-risk of metabolic disease and convey health benefits within the general population.
Delayed Timing of Eating: Impact on Weight and Metabolism. [2018]Animal studies of delayed eating have provided useful information regarding the potential relationship between nighttime eating and increased weight and metabolic dysregulation, which occur in the absence of increased locomotion or increased caloric intake. We first review recent studies detailing these relationships and possible mechanisms in rodents. We then examine human data showing that sleep restriction leads to increased energy intake and weight gain, followed by a review of the human phenotype of delayed eating, night eating syndrome, and its relation to weight and metabolism. Finally, we examine human experimental studies of delayed eating and discuss preliminary data that show slight weight gain, dysfunction in energy expenditure, and abnormalities in the circadian rhythms of appetitive, stress, and sleep hormones. Well-controlled, longer-term experimental studies in humans are warranted to test the effect of delayed eating without sleep restriction to clarify whether limiting or eliminating nighttime eating could lead to weight loss and significantly improve related disorders, such as diabetes and heart disease, over time.
Divided consumption of late-night-dinner improves glycemic excursions in patients with type 2 diabetes: A randomized cross-over clinical trial. [2022]To explore the acute effect of late-night-dinner and divided dinner on postprandial glucose levels in patients with type 2 diabetes.
Association of meal timing with body composition and cardiometabolic risk factors in young adults. [2023]To investigate the association of meal timing with body composition and cardiometabolic risk factors in young adults.
Timing of eating in adults across the weight spectrum: Metabolic factors and potential circadian mechanisms. [2023]Timing of eating is recognized as a significant contributor to body weight regulation. Disruption of sleep-wake cycles from a predominantly diurnal (daytime) to a delayed (evening) lifestyle leads to altered circadian rhythms and metabolic dysfunction. This article reviews current evidence for timed and delayed eating in individuals of normal weight and those with overweight or obesity: although some findings indicate a benefit of eating earlier in the daytime on weight and/or metabolic outcomes, results have not been uniformly consistent, and more rigorous and longer-duration studies are needed. We also review potential circadian mechanisms underlying the metabolic- and weight-related changes resulting from timed and delayed eating. Further identification of such mechanisms using deep phenotyping is required to determine targets for medical interventions for obesity and for prevention of metabolic syndrome and diabetes, and to inform clinical guidelines regarding eating schedules for management of weight and metabolic disease.
Timing Matters: The Interplay between Early Mealtime, Circadian Rhythms, Gene Expression, Circadian Hormones, and Metabolism-A Narrative Review. [2023]Achieving synchronization between the central and peripheral body clocks is essential for ensuring optimal metabolic function. Meal timing is an emerging field of research that investigates the influence of eating patterns on our circadian rhythm, metabolism, and overall health. This narrative review examines the relationship between meal timing, circadian rhythm, clock genes, circadian hormones, and metabolic function. It analyzes the existing literature and experimental data to explore the connection between mealtime, circadian rhythms, and metabolic processes. The available evidence highlights the importance of aligning mealtime with the body's natural rhythms to promote metabolic health and prevent metabolic disorders. Specifically, studies show that consuming meals later in the day is associated with an elevated prevalence of metabolic disorders, while early time-restricted eating, such as having an early breakfast and an earlier dinner, improves levels of glucose in the blood and substrate oxidation. Circadian hormones, including cortisol and melatonin, interact with mealtimes and play vital roles in regulating metabolic processes. Cortisol, aligned with dawn in diurnal mammals, activates energy reserves, stimulates appetite, influences clock gene expression, and synchronizes peripheral clocks. Consuming meals during periods of elevated melatonin levels, specifically during the circadian night, has been correlated with potential implications for glucose tolerance. Understanding the mechanisms of central and peripheral clock synchronization, including genetics, interactions with chronotype, sleep duration, and hormonal changes, provides valuable insights for optimizing dietary strategies and timing. This knowledge contributes to improved overall health and well-being by aligning mealtime with the body's natural circadian rhythm.
A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. [2022]A diurnal rhythm of eating-fasting promotes health, but the eating pattern of humans is rarely assessed. Using a mobile app, we monitored ingestion events in healthy adults with no shift-work for several days. Most subjects ate frequently and erratically throughout wakeful hours, and overnight fasting duration paralleled time in bed. There was a bias toward eating late, with an estimated 35% after 6 p.m. "Metabolic jetlag" resulting from weekday/weekend variation in eating pattern akin to travel across time zones was prevalent. The daily intake duration (95% interval) exceeded 14.75 hr for half of the cohort. When overweight individuals with >14 hr eating duration ate for only 10-11 hr daily for 16 weeks assisted by a data visualization (raster plot of dietary intake pattern, "feedogram") that we developed, they reduced body weight, reported being energetic, and improved sleep. Benefits persisted for a year.