Circadian Misalignment for Gender Differences in Metabolism

JQ
Overseen ByJingyi Qian, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how circadian misalignment, or being out of sync with the body's natural clock, affects hunger and blood sugar control differently in males and females. Researchers will examine whether working day shifts or night shifts alters these effects. This information could lead to more personalized work schedules and health care strategies. Suitable candidates are healthy non-smokers, aged 18-40, with a body mass index (BMI) between 18.5 and 24.9, who have not undergone gender-affirming treatments. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance health and work-life balance.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study requires participants to be healthy with no acute or chronic medical disorders, it's possible that certain medications might not be allowed. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this protocol is safe for participants?

Research has shown that working night shifts disrupts the body's natural schedule, causing it to fall out of sync with normal sleep and eating times. This disruption affects how the body handles sugar and fat, increasing the risk of obesity and diabetes.

For those working day shifts, studies suggest no major changes occur in how the body processes food. Working during the day is generally easier on the body and less likely to cause metabolic issues.

However, night shifts present more challenges. They can cause a mismatch between different parts of the body's internal clock, affecting sugar processing. Prolonged disruption may lead to metabolic problems.

In summary, while both day and night shifts are under study, night shifts appear to have a greater impact on metabolic health. Day shifts are generally well-tolerated, whereas night shifts might increase the risk of metabolic disruptions.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different work schedules, specifically day and night shifts, affect metabolism differently in men and women. This approach is unique because it examines how our body's internal clock, or circadian rhythm, might influence gender-specific metabolic processes. Understanding these differences can potentially lead to personalized treatment strategies for metabolic disorders, making it different from current one-size-fits-all approaches. By shifting focus from traditional medications to lifestyle factors like work schedules, this trial may uncover new ways to optimize metabolic health based on individual circadian rhythms.

What evidence suggests that this trial's treatments could be effective for circadian misalignment?

This trial will compare the effects of different shift schedules on metabolism. Research has shown that night shifts can disrupt the body's natural rhythm, affecting energy levels and metabolism in both men and women. Studies have found that night shift work can reduce daily energy expenditure, potentially leading to weight gain and obesity. Men and women may react differently to these changes, with some evidence suggesting that women experience more significant disruptions in energy balance. One study found that night shifts can impair the body's ability to process sugar. These findings suggest that the timing of work shifts could affect metabolic health differently for men and women. Participants in this trial will experience both shift schedules to assess these effects.12367

Who Is on the Research Team?

JQ

Jingyi Qian, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-40 who are non-smokers, have a normal weight, and no history of medical or psychiatric disorders. Participants must not be pregnant and should not have used gender-affirming hormones or had related surgeries.

Inclusion Criteria

I am between 18 and 40 years old.
Non-smokers, no current tobacco or e-cigarette use
Body Mass Index 18.5-24.9 kg/m2
See 2 more

Exclusion Criteria

History of drug or alcohol dependency
History of psychiatric illness or disorder
Pregnant
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Day Shift Protocol

Participants follow a day shift protocol to assess metabolic responses

1 week
Daily monitoring

Night Shift Protocol

Participants follow a night shift protocol to assess metabolic responses

1 week
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after protocol completion

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Day shift
  • Night shift

Trial Overview

The study compares how working day shifts versus night shifts (causing jet lag-like effects) impacts hunger and blood sugar control in males and females to see if there are sex-specific differences in response to circadian misalignment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Night shift -> Day shiftExperimental Treatment2 Interventions
Group II: Day Shift -> Night ShiftExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

Circadian Misalignment for Gender Differences in ...

This study will test whether biological sex influences how the body responds to circadian misalignment-a mismatch between the internal body ...

Sex differences in the circadian misalignment effects on ... - PMC

Here we show that circadian misalignment disrupts energy balance in females and males through different pathways. Females had more disturbances ...

Impact of circadian misalignment on energy metabolism ...

We demonstrate that nightshift work reduces total daily energy expenditure, representing a contributing mechanism for unwanted weight gain and obesity.

Sex differences in sleep, circadian rhythms, and metabolism

Survey data from a large Swedish working sample revealed similar odds of obesity for males (OR, 95%. CI: 1.44, 1.27–1.64) and females (OR, 95% CI: 1.39, 1.25– ...

Does Circadian Misalignment Have Sex-Specific Effects on ...

Researchers will examine how circadian misalignment affects appetite regulation (hunger/fullness) and glucose metabolism (blood sugar control), ...

Day shift protocol (top) and night shift protocol (bottom) as ...

Our results indicate that chronic exposure to DLE causes circadian misalignment without significant accompanying metabolic changes. Future studies should ...

Daytime eating prevents internal circadian misalignment ...

Nighttime eating led to misalignment between central and peripheral (glucose) endogenous circadian rhythms and impaired glucose tolerance.