NCT07441265

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
49mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Circadian MisalignmentSex Differences

Keywords

circadian rhythmsex differencesnight workglucose controlappetite regulation

Outcome Measures

Primary Outcomes (3)

  • 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

    24 hours

  • 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

    3 hours

  • 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.

    16 hours

Study Arms (2)

Day Shift -> Night Shift

EXPERIMENTAL

Day Shift protocol first, then Night Shift protocol

Behavioral: Day shiftBehavioral: Night shift

Night shift -> Day shift

EXPERIMENTAL

Night shift protocol first, then Day Shift protocol

Behavioral: Day shiftBehavioral: Night shift

Interventions

Day shiftBEHAVIORAL

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

Day Shift -> Night ShiftNight shift -> Day shift
Night shiftBEHAVIORAL

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

Day Shift -> Night ShiftNight shift -> Day shift

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Shift Work Schedule

Intervention Hierarchy (Ancestors)

Personnel Staffing and SchedulingPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Officials

  • Jingyi Qian, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyi Qian, PhD

CONTACT

617-525-7423jqian5@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)