Meal Timing for Obesity

(CM Trial)

Recruiting at 1 trial location

Overseen By Claudia Dreyer

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Antidepressants, Psychoactive, Hypnotic, others

Disqualifiers: Sleep disorders, Psychiatric disorders, Smoking, others

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

Compensation: Varies

Number of Visits: 6

42 Participants Needed

Trial Summary

What is the purpose of this trial?

Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.

Will I have to stop taking my current medications?

The trial requires that participants do not take certain medications, such as psychoactive or hypnotic medications, chronic pain or anti-inflammatory medications, and beta blockers. If you are taking any of these, you may need to stop before joining the trial.

What data supports the effectiveness of the treatment Meal Timing for Obesity?

Research suggests that inconsistent eating times and prolonged eating windows are linked to higher body weight and obesity. Studies show that regular meal timing and shorter eating windows can help with weight loss, indicating that meal timing could be an effective treatment for obesity. ^{1 2 3 4 5}

Is meal timing safe for humans?

Research suggests that adjusting meal timing, such as eating earlier in the day, is generally safe and may even improve weight and metabolism in healthy adults. However, more long-term studies are needed to fully understand its safety and effects. ^{2 6 7 8 9}

How does meal timing as a treatment for obesity differ from other treatments?

Meal timing as a treatment for obesity is unique because it focuses on the timing of food intake rather than the type or amount of food consumed. This approach aims to align eating patterns with the body's natural circadian rhythms, potentially improving metabolism and aiding weight control, unlike traditional methods that primarily focus on calorie restriction or specific diets. ^{1 2 5 10 11}

Research Team

Marie-Pierre St-Onge, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults with obesity (BMI of 25-34.9) who usually sleep at least 7 hours, starting at or before 4 AM, and eat within an hour of waking up. It's open to all races and ethnicities. People can't join if they have sleep disorders, severe insomnia, psychiatric conditions, recent significant weight changes, are pregnant or post-partum within a year, have high alcohol intake or substance abuse history.

Inclusion Criteria

Body mass index 25-34.9 kg/m2

Average sleep duration ≥7 hour/night, assessed during 2-week screening period

All racial and ethnic groups

Exclusion Criteria

Current or past psychiatric disorder, including eating disorders and seasonal affective disorder

Any psychological or psychiatric disorder deemed to interfere with study outcomes

Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers <3 years)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Circadian Alignment Phase

Participants consume meals aligned to the sleep episode, from 9 AM to 7 PM

2 weeks

Measurements taken after 3 and 14 days

Circadian Misalignment Phase

Participants consume meals misaligned to the sleep episode, from 1 PM to 11 PM

2 weeks

Measurements taken after 3 and 14 days

Free-living Period

Participants follow prescribed meal times for each phase in a free-living environment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Meal times

Trial Overview The study investigates how the timing of meals and sleep affects body weight regulation without changing sleep duration. It aims to provide guidance on meal and sleep scheduling that could benefit shift workers or those experiencing jetlag.

Participant Groups

Group I: Circadian misalignment Experimental Treatment 1 Intervention

Meals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM.

Group II: Circadian alignment Active Control 1 Intervention

Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Findings from Research

In a study of 49 adults undergoing colon cancer screening, those with inconsistent eating times had a significantly higher Body Mass Index (BMI) compared to those with consistent eating habits, indicating a potential link between eating patterns and obesity.

Specifically, individuals who ate inconsistently and late had the highest average BMI, suggesting that irregular meal timing may contribute to metabolic dysregulation and obesity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inconsistent eating time is associated with obesity: A prospective study. Adnan, D., Trinh, J., Bishehsari, F.[2022]

In a study of 85 adults with overweight or obesity, the median eating window was found to be over 14 hours, indicating prolonged eating patterns throughout the day.

Participants had significantly shorter eating windows on weekends compared to weekdays, suggesting that eating timing may vary based on daily routines, which could impact weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity. Popp, CJ., Curran, M., Wang, C., et al.[2022]

In a study of 637 women participating in weight loss programs, both meal time regularity (MTR) and calorie intake regularity (CIR) were found to significantly contribute to weight loss, indicating that consistent meal timing and calorie amounts can enhance weight loss efforts.

Subjects who maintained equal calorie intake at each meal lost more weight compared to those with irregular calorie consumption, suggesting that not just what you eat, but when and how consistently you eat can impact weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between meal regularity and weight loss among women in commercial weight loss programs. Eom, H., Lee, D., Cho, Y., et al.[2022]

In a 12-week study involving 91 overweight/obese non-shift workers, those who achieved a satisfactory weight loss (≥3% body weight) had a significantly higher intake of protein earlier in the day and reduced fat intake later in the day, indicating that timing and composition of meals are crucial for weight loss success.

Participants with satisfactory weight loss also had earlier last meal times and shorter eating windows, along with a notable reduction in night eating syndrome scores, suggesting that chrono-nutrition practices can effectively support weight reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in chrono-nutrition is associated with robust weight loss outcomes: An extension of the feasibility study. Mazri, FH., Manaf, ZA., Shahar, S., et al.[2023]

In a study of 81 adults with obesity, those with a morning chronotype (MC) spent significantly more time eating lunch and dinner compared to evening chronotype (EC) individuals, who ate faster.

The faster eating speed of EC individuals may contribute to their higher risk of obesity-related cardiometabolic diseases, highlighting the importance of chronotype in dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Fast Do "Owls" and "Larks" Eat? Verde, L., Docimo, A., Chirico, G., et al.[2023]

An 8-week daytime eating schedule significantly promotes weight loss and improves energy metabolism and insulin sensitivity in healthy adults with a BMI of 19-27 kg/m2, compared to a delayed eating schedule.

Participants on the delayed eating schedule experienced increases in body weight, insulin resistance, and triglycerides, highlighting the negative metabolic effects associated with eating later in the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism. Allison, KC., Hopkins, CM., Ruggieri, M., et al.[2022]

A systematic review of 34 studies found that irregular eating patterns, characterized by between-day variability in meal frequency, are linked to negative health outcomes such as higher body weight and poorer cognitive performance.

Current methods for measuring meal pattern variability are inconsistent and often based on assumptions, highlighting the need for more rigorous dietary intervention studies to establish clear causal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of associations between day-to-day variability in meal pattern and body weight, components of the metabolic syndrome and cognitive function. Ali, MA., Macdonald, IA., Taylor, MA.[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]

Current evidence suggests that increasing the fasting period between meals may be more beneficial for weight control and metabolic health than the traditional approach of eating multiple small meals throughout the day.

This review highlights the importance of meal timing and frequency in managing body weight and metabolic health, indicating that more research is needed to fully understand these effects under different energy balance conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic impacts of altering meal frequency and timing - Does when we eat matter? Hutchison, AT., Heilbronn, LK.[2017]

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 of 3,658 Korean men aged 18 to 60, disruptions in circadian rhythm, such as irregular breakfast frequency and inadequate sleep duration, were linked to a higher risk of general obesity, with adjusted odds ratios indicating a significant increase in risk for those with one or more disrupting factors.

Men with two or more circadian rhythm disturbances had an even greater risk for both general (aOR 1.62) and abdominal obesity (aOR 1.70), highlighting the importance of maintaining a regular circadian rhythm for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between misalignment of circadian rhythm and obesity in Korean men: Sixth Korea National Health and Nutrition Examination Survey. Kim, HJ., Choi, S., Kim, K., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Inconsistent eating time is associated with obesity: A prospective study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The association between meal regularity and weight loss among women in commercial weight loss programs. [2022]

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

Improvement in chrono-nutrition is associated with robust weight loss outcomes: An extension of the feasibility study. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

How Fast Do "Owls" and "Larks" Eat? [2023]

6. England pubmed.ncbi.nlm.nih.gov

Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review of associations between day-to-day variability in meal pattern and body weight, components of the metabolic syndrome and cognitive function. [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. France pubmed.ncbi.nlm.nih.gov

Metabolic impacts of altering meal frequency and timing - Does when we eat matter? [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Association between misalignment of circadian rhythm and obesity in Korean men: Sixth Korea National Health and Nutrition Examination Survey. [2021]