Circadian MisalignmentNCT07441265
Does Circadian Misalignment Have Sex-Specific Effects on Metabolism?
A study testing Day shift and Night shift in people with Circadian Misalignment and Sex Differences, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Misalignment, Sex Differences
- What is being tested?
- Day shift and Night shift
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
- Pregnant
- No prior gender-affirming hormone therapy and no gonadectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Vy Nguyen, B.S., (617)-525-0662, vnguyen42@bwh.harvard.edu
About this study
Official title: Role of Biological Sex in Metabolic Responses to Night Work
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.
Read the detailed description
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.
- Conditions
- Circadian Misalignment, Sex Differences
- Being tested
- Day shift, Night shift
- Keywords
- circadian rhythm, sex differences, night work, glucose control, appetite regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day shiftBehavioural
Research participants will be assigned to day shift condition in which sleep-wake and meal schedules are aligned with the internal circadian system
Night shiftBehavioural
Research participants will be assigned to simulated night shift condition in which sleep-wake and meal schedules are misaligned with the internal circadian system
| Study group | Role | What they receive |
|---|---|---|
| Day Shift -> Night Shift | Experimental | Day Shift protocol first, then Night Shift protocol Receives: Behavioral: Day shift; Behavioral: Night shift |
| Night shift -> Day shift | Experimental | Night shift protocol first, then Day Shift protocol Receives: Behavioral: Day shift; Behavioral: Night shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian MisalignmentStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Qian, Brigham and Women's Hospital
- Investigators
- Jingyi Qian, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441265
- Sponsor's protocol ID
- 2026P000307
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Biological Sex in Metabolic Responses to Night Work
- ClinicalTrials.gov ID
- NCT07441265
- Acronym / sponsor ID
- 2026P000307
- Conditions
- Circadian Misalignment, Sex Differences
- Keywords
- circadian rhythm, sex differences, night work, glucose control, appetite regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Shift -> Night Shift | Experimental | Behavioral: Day shift, Behavioral: Night shiftDay Shift protocol first, then Night Shift protocol |
| Night shift -> Day shift | Experimental | Behavioral: Day shift, Behavioral: Night shiftNight shift protocol first, then Day Shift protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
- Pregnant
- No prior gender-affirming hormone therapy and no gonadectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day shiftResearch participants will be assigned to day shift condition in which sleep-wake and meal schedules are aligned with the internal circadian system | Behavioural | Day Shift -> Night Shift, Night shift -> Day shift |
| Night shiftResearch participants will be assigned to simulated night shift condition in which sleep-wake and meal schedules are misaligned with the internal circadian system | Behavioural | Day Shift -> Night Shift, Night shift -> Day shift |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Circadian Misalignment
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
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Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Recruiting
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Cushing Syndrome, Adrenal Insufficiency
Recruiting
Mind After Midnight
Suicidal Ideation, Circadian Rhythm Disorders
Active, not recruiting
Circadian Misalignment and Energy Balance
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingyi Qian, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day shift and Night shift in people with Circadian Misalignment and Sex Differences, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Qian, PhD (617-525-7423, jqian5@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in circulating leptin levels between Night Shift and Day Shift (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.