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NCT Number: NCT07441265

Does Circadian Misalignment Have Sex-Specific Effects on Metabolism?

This study will test whether biological sex influences how the body responds to circadian misalignment-a mismatch between the internal body clock and the timing of sleep and eating (as can occur with shift work or jet lag). Researchers will examine how circadian misalignment affects appetite regulation (hunger/fullness) and glucose metabolism (blood sugar control), and whether these effects differ between females and males. Findings may help inform more personalized shift work schedules and targeted strategies to reduce metabolic health risks and sex-related differences in clinical care.

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Key information

Conditions

Circadian Misalignment Sex Differences

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study will examine whether biological sex affects how the body responds to circadian misalignment-a mismatch between a person's internal body clock and their sleep/wake and eating schedule (similar to what can happen with night shift work, jet lag, or frequently changing sleep schedules). Researchers will measure how circadian misalignment influences appetite regulation (such as hunger and fullness) and glucose metabolism (how the body controls blood sugar), and whether these effects differ between females and males.

By identifying sex-specific responses to circadian misalignment, this research may help guide the development of safer, more personalized shift work schedules and targeted strategies to reduce metabolic health risks, with the goal of improving clinical care and reducing sex-related differences in metabolic disease risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-40 years of age
  • Body Mass Index 18.5-24.9 kg/m2
  • Non-smokers, no current tobacco or e-cigarette use
  • Healthy with no acute or chronic medical and psychiatric disorders
  • Sex assigned at birth consistent with reproductive anatomy at enrollment (per protocol definition)

Exclusion criteria

  • History of drug or alcohol dependency
  • History of psychiatric illness or disorder
  • Pregnant
  • No prior gender-affirming hormone therapy and no gonadectomy

Treatment and study plan

Day shift

Behavioral

Research participants will be assigned to day shift condition in which sleep-wake and meal schedules are aligned with the internal circadian system

Night shift

Behavioral

Research participants will be assigned to simulated night shift condition in which sleep-wake and meal schedules are misaligned with the internal circadian system

Primary outcomes

  1. Difference in circulating leptin levels between Night Shift and Day Shift

    Time frame: 24 hours

    Differences of 24-h circulating leptin levels on the test days in the two experimental conditions

  2. Differences in Disposition index (DI) derived from identical test breakfast between Night Shift and Day Shift

    Time frame: 3 hours

    Disposition index (DI) derived from oral minimal model based on postprandial glucose, insulin, and c-peptide responses to identical test breakfast on the test days between protocols

  3. Differences in self-rated cravings for hyperpalatable food during the wake period between Night Shift and Day Shift.

    Time frame: 16 hours

    Differences in self-rated cravings for hyperpalatable food during the wake period on the test days between protocols.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyi Qian, PhD

CONTACT

[email protected]

617-525-7423

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Role of Biological Sex in Metabolic Responses to Night Work

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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