Meal Timing and Sleep for Metabolic Health in Healthy Subjects

(DT2 Trial)

No longer recruiting at 1 trial location

Overseen By Mariah Potocki, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Sedatives, Anxiolytics, Opiates, others

Disqualifiers: Sleep disorders, Diabetes, Kidney disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dinner timing might affect metabolism and sleep in healthy adults. Researchers will compare the effects of eating dinner early (Early Dinner) or late (Late Dinner) and examine how delaying sleep might further impact the body's ability to process nutrients and fats. Participants will be divided into groups to try different combinations of eating and sleeping times. The trial seeks healthy adults who usually go to bed before 1:00 A.M. and do not have any sleep disorders or metabolic diseases. As an unphased trial, it offers participants the opportunity to contribute to understanding how lifestyle changes can impact health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dinner timing can affect health, but changing meal times is generally safe. Studies have found that eating dinner earlier may improve energy processing, benefiting metabolism. Specifically, the body might manage sugars and fats more effectively with earlier meals.

Conversely, a late dinner might hinder fat burning, which could be less beneficial for metabolism. However, this doesn't imply it's unsafe; it just might not align with certain health goals.

Eating dinner and going to bed later can reduce nighttime fat burning, affecting energy use. While not necessarily harmful, it might not be ideal for boosting metabolism.

Overall, most people can adjust meal times without issues. Studies have not reported major safety concerns. Participants in similar studies adapted well, experiencing no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the timing of meals and sleep can impact metabolic health, which is a fresh approach compared to traditional methods like diet adjustments or medication. Unlike standard practices that often focus on what you eat, this study looks at when you eat and sleep, offering a new angle on metabolic regulation. By using stable isotopes to measure fat oxidation, the trial can provide deeper insights into the body's metabolic processes, potentially leading to novel strategies for maintaining or improving metabolic health. This could pave the way for personalized lifestyle recommendations that are easy to implement and could complement or enhance existing health strategies.

What evidence suggests that this trial's treatments could be effective for metabolic health?

This trial will compare different meal timing and sleep patterns. Studies have shown that eating dinner late can disrupt how the body processes sugar and fat, potentially leading to weight gain and other health issues. Participants will experience various meal timings, including a late dinner, which might affect energy use during sleep. Research suggests that eating dinner earlier can aid in weight loss and help avoid these issues. Another part of the trial will examine the effects of eating late and going to bed even later, which can disrupt the body's internal clock and possibly lead to obesity. Eating dinner earlier may help maintain the body's natural rhythms, improving overall health. ^{1 2 3 6 7}

Who Is on the Research Team?

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Early dinner
• Late Dinner
• Late Dinner + Late Sleep

Trial Overview 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.

How Is the Trial Designed?

Group I: Late Dinner first Experimental Treatment 3 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 first Experimental Treatment 3 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 first Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Marrow Donor Program

Collaborator

Trials

63

Recruited

202,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Published Research Related to This Trial

In a study of 118 young adults, meal timing did not show a significant association with body composition, indicating that when you eat may not affect weight or fat levels.

However, a longer eating window and earlier first food intake after sleep were linked to improved cardiometabolic health in men, suggesting that meal timing could influence metabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of meal timing with body composition and cardiometabolic risk factors in young adults. Dote-Montero, M., Acosta, FM., Sanchez-Delgado, G., et al.[2023]

Eating earlier in the day may help with weight management and metabolic health, but the evidence is inconsistent, highlighting the need for more rigorous and longer studies.

Understanding the circadian mechanisms behind how eating timing affects metabolism could lead to better medical interventions for obesity and metabolic diseases, and help shape clinical guidelines for eating schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of eating in adults across the weight spectrum: Metabolic factors and potential circadian mechanisms. Allison, KC., Goel, N.[2023]

Research indicates that the timing of food intake is significantly associated with obesity and metabolic health, suggesting that when we eat may be as important as what and how much we eat.

Eating earlier in the day is linked to benefits such as reduced weight gain and lower risks of hyperglycemia and diabetes, highlighting meal timing as a potential target for obesity prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of food intake: Sounding the alarm about metabolic impairments? A systematic review. Beccuti, G., Monagheddu, C., Evangelista, A., et al.[2018]

In a study involving 20 healthy adults, having dinner 1 hour before bedtime (late dinner) did not significantly harm sleep architecture compared to eating 5 hours before (routine dinner).

Interestingly, late dinner was associated with deeper sleep at the beginning of the night, suggesting that this eating pattern might have potential benefits for individuals with sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. Duan, D., Gu, C., Polotsky, VY., et al.[2022]

A study using a mobile app to track eating patterns in healthy adults revealed that most people eat erratically throughout the day, with a significant portion of calories consumed late in the evening, leading to a daily eating duration exceeding 14.75 hours for many participants.

Overweight individuals who reduced their eating window to 10-11 hours daily for 16 weeks, using a visual tool to track their intake, experienced weight loss, increased energy levels, and improved sleep, with these benefits lasting for a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Gill, S., Panda, S.[2022]

In a study of 133 women, those who had the shortest time between dinner and the midpoint of sleep (TDM) had significantly higher body mass index (BMI) and waist circumference, suggesting that meal timing relative to sleep may influence obesity risk.

A TDM of 6 hours was associated with the lowest levels of adiposity, indicating that adjusting meal timing to align with individual sleep/wake schedules could be an effective strategy for obesity prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Elapsed Time between Dinner and the Midpoint of Sleep is Associated with Adiposity in Young Women. Zerón-Rugerio, MF., Longo-Silva, G., Hernáez, Á., et al.[2020]

In a study involving 16 patients with type 2 diabetes, consuming dinner late at 2100h resulted in significantly higher post-meal glucose levels compared to having dinner at 1800h, indicating a risk of postprandial hyperglycemia.

Dividing dinner into two parts, with the first part at 1800h and the second at 2100h, significantly reduced postprandial glucose levels, suggesting that meal timing and distribution can effectively manage glucose spikes in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divided consumption of late-night-dinner improves glycemic excursions in patients with type 2 diabetes: A randomized cross-over clinical trial. Imai, S., Kajiyama, S., Hashimoto, Y., et al.[2022]

Aligning meal times with the body's natural circadian rhythms is crucial for promoting metabolic health and preventing disorders, as late meals are linked to higher rates of metabolic issues.

Early time-restricted eating, such as having breakfast early and dinner earlier, has been shown to improve blood glucose levels and metabolic processes, highlighting the importance of meal timing in relation to circadian hormones like cortisol and melatonin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing Matters: The Interplay between Early Mealtime, Circadian Rhythms, Gene Expression, Circadian Hormones, and Metabolism-A Narrative Review. BaHammam, AS., Pirzada, A.[2023]

Chrono-nutrition, which focuses on aligning eating patterns with our body's natural circadian rhythms, shows promise in improving metabolic health by optimizing the timing of food intake.

Research indicates that eating earlier in the day may enhance metabolic processes like glucose and lipid management, suggesting that meal timing could be a key factor in preventing metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. Flanagan, A., Bechtold, DA., Pot, GK., et al.[2021]

Animal studies suggest that delayed eating at night can lead to weight gain and metabolic issues without increased physical activity or caloric intake, indicating a potential link between nighttime eating and health problems.

Human studies show that sleep restriction is associated with increased energy intake and weight gain, and preliminary data suggest that delayed eating may disrupt energy expenditure and circadian rhythms, highlighting the need for further long-term studies to explore the effects of nighttime eating on weight and metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Timing of Eating: Impact on Weight and Metabolism. Allison, KC., Goel, N., Ahima, RS.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6893547/

Timing of Breakfast, Lunch, and Dinner. Effects on Obesity and ... Results showed that late lunch eaters (after 3 p.m.) lost less weight during the treatment than early lunch eaters (before 3 p.m.), in spite of having similar ...

2. trialx.com trialx.com/clinical-trials/listings/263848/dinner-time-2-effect-of-delayed-eating-or-sleeping-on-metabolism/

Dinner Time 2: Effect of Delayed Eating or Sleeping on ... The investigators will compare (1) the impact of early dinner time with later dinner time relative to DLMO with a routine sleep time; and (2) ...

3. withpower.com withpower.com/trial/phase-2021-f2c0f

Meal Timing and Sleep for Metabolic Health in Healthy ... In a study involving 20 healthy adults, having dinner 1 hour before bedtime (late dinner) did not significantly harm sleep architecture compared to eating 5 ...

4. ctv.veeva.com ctv.veeva.com/study/dinner-time-2-effect-of-delayed-eating-or-sleeping-on-metabolism

Dinner Time 2: Effect of Delayed Eating or Sleeping on ... This study examines the acute impact of eating an "early" versus "late" dinner. "Early" and "late" will be customized to individuals based ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960982217305043

Meal Timing Regulates the Human Circadian System The glucose acrophase occurred 1.31 ± 0.82 hr before DLMO following early meals but 4.38 ± 0.83 hr after DLMO following late meals. The 5-hr ...

6. researchgate.net researchgate.net/publication/364366950_Delaying_mealtimes_reduces_fat_oxidation_A_randomized_crossover_controlled_feeding_study

Delaying mealtimes reduces fat oxidation: A randomized, ... Objective This study investigated the effects of circadian misalignment (CM), induced by delaying mealtimes, independent of sleep timing and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9691571/

Delaying meal times reduces fat oxidation - PubMed Central Experimental studies show that late meal timing results in metabolic dysfunction (15–17), while earlier meal timing improves energy metabolism ( ...