Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
32 participants
INTERVENTIONAL
2021-07-07
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Circadian Intervention to Improve Cardiometabolic Health
NCT05943626
Circadian Misalignment and Energy Balance
NCT03663530
The Microbiome and Resilience to Sleep and Circadian Disruption
NCT03747367
Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
NCT02291952
Nighttime Synchrony of Your Nutrition and Circadian Health
NCT07329283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Therefore, the long-term goal is to identify and develop effective, behavioral countermeasures to combat the increased risk for metabolic diseases associated with sleep and circadian disruption when these behaviors are unavoidable. The overall objective for this project is to test the impact of time-restricted feeding to a 7h period in the day as a noninvasive countermeasure to the metabolic impairments associated with circadian misalignment. The central hypothesis is that time-restricted feeding to the daytime period will prevent metabolic impairments during circadian misalignment compared to a condition where energy is consumed throughout the day and night. The rationale for the proposed project is that defining a non-invasive, scalable and feasible countermeasure to circadian misalignment could mitigate the risk of obesity and T2D.
To test the overall hypothesis, a randomized crossover study will be used with a rigorous inpatient diet, activity and light-controlled protocol in healthy men and women. The impact of time restricted feeding during circadian misalignment on metabolic homeostasis will be determined.
Findings from this study represent a critical advancement in the fields of translational circadian and metabolic physiology by identifying and testing a countermeasure to circadian misalignment. Achievement of the proposed aims could lead to the development of new intervention strategies for chronic disease prevention and management. The knowledge to be gained offers the potential to support cost-effective programs that may inform healthcare approach to metabolic disease prevention in populations at risk for these diseases such as shift workers, individuals with sleep disorders and anyone who eats outside of daytime hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Circadian misalignment (Condition A)
Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts.
Circadian Misalignment
Healthy lean subjects will undergo circadian misalignment induced using a simulated night shift-work protocol in both conditions of the study. Each condition will last approximately 6 days.
Circadian misalignment with time-restricted feeding (Condition B)
Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts.
Time-restricted feeding
Each subject will participate in both conditions (CM and CM+TRF)--one in which food is allowed during the nighttime period and one in which food will be restricted to the daytime only. Food intake will be matched across conditions and designed to keep participants weight stable.
Circadian Misalignment
Healthy lean subjects will undergo circadian misalignment induced using a simulated night shift-work protocol in both conditions of the study. Each condition will last approximately 6 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Time-restricted feeding
Each subject will participate in both conditions (CM and CM+TRF)--one in which food is allowed during the nighttime period and one in which food will be restricted to the daytime only. Food intake will be matched across conditions and designed to keep participants weight stable.
Circadian Misalignment
Healthy lean subjects will undergo circadian misalignment induced using a simulated night shift-work protocol in both conditions of the study. Each condition will last approximately 6 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body Mass Index (BMI) between 20.0 and 24.9 ("normal" weight).
3. Physical activity history: inactive to habitual moderate physical activity level
4. Sleep/wake history: habitual sleep duration between 7-9.25 hours.
5. Altitude history: Potential subjects must have lived at Denver altitude or higher for at least 3 months prior to inpatient stay.
Exclusion Criteria
2. Use of prescribed medications/supplements/illicit drugs within one month prior to study
3. History of shift work in year prior to study, or travel more than one time zone in three weeks prior to study. \[NOTE: Subjects can be studied at a later date.\]
4. Women with history of prior gynecological pathology, \<1 year post-partum, breast-feeding and/or pregnant.
5. Non-English speakers will be excluded, as we do not have access to a translator who could rely accurate information to the participant for the consent or throughout the study.
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Colorado, Denver
OTHER
Salk Institute for Biological Studies
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Colorado State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colorado State University
Fort Collins, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Josiane Broussard's Bibliography
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-9666H
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.