Does Circadian Misalignment Have Sex-Specific Effects on Metabolism?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Day shift, Night shift.
- Who it may be relevant to
- Registry conditions: Circadian Misalignment, Sex Differences. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Biological Sex in Metabolic Responses to Night Work
Overview
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.
Interventions
- Behavioral Day shift
Research participants will be assigned to day shift condition in which sleep-wake and meal schedules are aligned with the internal circadian system - Behavioral Night shift
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 outcome measures
- Difference in circulating leptin levels between Night Shift and Day Shift [Time frame: 24 hours]
- Differences in Disposition index (DI) derived from identical test breakfast between Night Shift and Day Shift [Time frame: 3 hours]
- Differences in self-rated cravings for hyperpalatable food during the wake period between Night Shift and Day Shift. [Time frame: 16 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT07441265 · 2026P000307