Meal Timing for Metabolism

Overseen By Erin Hanlon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Melatonin, Psychoactive, Hypnotic, Stimulant

Disqualifiers: Diabetes, Sleep disorders, Major psychiatric, others

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

Compensation: Varies

Number of Visits: 6

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine how the timing of eating changes how the body makes and uses energy (metabolism). This study will also examine if metabolism changes with age.

Do I need to stop my current medications for the trial?

The trial requires that you have not used melatonin, psychoactive, hypnotic, stimulant, or pain medications (except occasionally), or beta blockers within the past month. If you are currently using these, you may need to stop before participating.

Is meal timing generally safe for humans?

Research on meal timing, such as eating late or early, shows it can affect hunger, energy use, and metabolism, but there are no reports of serious safety concerns for humans. These studies suggest that while meal timing can influence weight and metabolic health, it is generally safe for people to participate in such trials. ^{1 2 3 4 5}

How does the 'Meal Timing for Metabolism' treatment differ from other treatments for weight management?

The 'Meal Timing for Metabolism' treatment is unique because it focuses on the timing of meals in relation to the body's internal clock, rather than just the quantity or type of food consumed. This approach considers how eating at different times of the day can affect metabolism and weight, potentially offering a novel way to manage weight by aligning meal times with the body's natural rhythms. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Early Total Caloric Intake, Extended Overnight Fast, Late Total Caloric Intake for metabolism?

Research shows that eating earlier in the day aligns with our body's natural rhythms and can help with weight loss and metabolism. Studies also suggest that delaying meals can lead to weight gain and metabolic issues, while eating during the day can improve weight and energy metabolism. ^{2 3 10 11 12}

Who Is on the Research Team?

Eve Van Cauter, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for healthy overweight or obese adults aged 30-75 with a BMI between 25 and less than 40, who sleep between 6.5 to 9 hours nightly within specific hours. Excluded are those with dietary restrictions, certain blood conditions, diabetes, unstable medical issues, recent surgeries or clinical study participation, menopause or pregnancy in women, and various medication uses.

Inclusion Criteria

Signed informed consent

My BMI is between 25 and 40, and I am considered overweight or obese but otherwise healthy.

signed informed consent

Exclusion Criteria

You have a gastrointestinal (GI) disease that requires you to make changes to your diet.

Members of the study team

My hemoglobin level is above 11.5g/dL if female, or above 13.5g/dL if male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessment of habitual sleep, meal timing, and caloric distribution under real-life conditions

1 week

Intervention

Participants undergo a 6-day semi-ambulatory inpatient intervention with different caloric distribution models

6 days

6 days (inpatient)

Post-Intervention Assessment

Repeat short laboratory session to assess changes in metabolic and cardiovascular profiles

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Early Total Caloric Intake
• Extended Overnight Fast
• Late Total Caloric Intake

Trial Overview The study investigates how eating times affect body metabolism and energy use. Participants will follow different schedules of caloric intake: early total intake versus late intake and an extended overnight fast to see if these factors influence metabolic changes as people age.

How Is the Trial Designed?

Group I: Late Total Caloric Intake Experimental Treatment 1 Intervention

The Late Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 40% of daily calories during breakfast and lunch. The remaining 60% of daily calories will be consumed during dinner. This is a model for late dietary chronotype.

Group II: Early Total Caloric Intake Experimental Treatment 1 Intervention

The Early Total Caloric Intake study group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session and will consume 60% of their daily calories during breakfast. The remaining 40% of daily calories will be consumed during lunch and dinner. This is a model for early dietary chronotype.

Group III: Extended Overnight Fast Active Control 1 Intervention

The extended overnight fast group will have scheduled meal times for the entire 6 day semi ambulatory and in lab session. Subjects will consume approximately 33% of their daily calories at breakfast, lunch and dinner, respectively. This is a model for fasting dietary chronotype.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

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]

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 randomized controlled trial found that late eating significantly increased hunger and altered appetite-regulating hormones, leading to a higher ghrelin-to-leptin ratio, which can promote weight gain.

Late eating also decreased energy expenditure and core body temperature, while affecting adipose tissue gene expression in ways that may increase fat storage and decrease fat breakdown, suggesting multiple mechanisms that contribute to obesity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Vujović, N., Piron, MJ., Qian, J., 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nutrient timing and metabolic regulation. [2022]

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

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

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

Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Fasting until Noon (Extended Postabsorptive State) on Clock Gene mRNA Expression and Regulation of Body Weight and Glucose Metabolism. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. [2023]

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

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

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

Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial. [2021]

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

Impact of circadian misalignment on energy metabolism during simulated nightshift work. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The Big Breakfast Study: Chrono-nutrition influence on energy expenditure and bodyweight. [2021]

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

Later circadian timing of food intake is associated with increased body fat. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Phenotypic vulnerability of energy balance responses to sleep loss in healthy adults. [2018]