Meal Timing and Sleep for Metabolic Health in Healthy Subjects

(DT2 Trial)

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

66 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 7 9 10}

Research Team

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Elapsed Time between Dinner and the Midpoint of Sleep is Associated with Adiposity in Young Women. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Timing of food intake: Sounding the alarm about metabolic impairments? A systematic review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. [2021]

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

Delayed Timing of Eating: Impact on Weight and Metabolism. [2018]

6. Ireland 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Association of meal timing with body composition and cardiometabolic risk factors in young adults. [2023]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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