Health TrialsbyHealthPanel

Does Circadian Misalignment Have Sex-Specific Effects on Metabolism?

ConditionsCircadian MisalignmentSex Differences
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of drug or alcohol dependency

History of psychiatric illness or disorder

Pregnant

No prior gender-affirming hormone therapy and no gonadectomy

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Day Shift -> Night ShiftExperimental treatment 2 interventions
Group B: Night shift -> Day shiftExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Difference in circulating leptin levels between Night Shift and Day Shift

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

Time frame
24 hours
2

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

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

Time frame
3 hours
3

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

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

Time frame
16 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: