NCT04966351 · Colorado State University
Countermeasures to Circadian Misalignment
(C2CM)
What this study is about
Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable.
View original scientific description
Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable. 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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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.
Primary outcome measures
Insulin sensitivity-derived from glucose tolerance test
Time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
Muscle tissue lipids-assessed by lipidomic analyses
Time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-35 old; men and women; equal numbers of women and men will be included.
- Body Mass Index (BMI) between 20.0 and 24.9 ("normal" weight).
- Physical activity history: inactive to habitual moderate physical activity level
- Sleep/wake history: habitual sleep duration between 7-9.25 hours.
- Altitude history: Potential subjects must have lived at Denver altitude or higher for at least 3 months prior to inpatient stay.
Exclusion criteria
- Any clinically significant medical, psychiatric, or sleep disorder
- Use of prescribed medications/supplements/illicit drugs within one month prior to study
- History of shift work in year prior to study, or travel more than one time zone in three weeks prior to study. \[NOTE: Subjects can be studied at a later date.\]
- Women with history of prior gynecological pathology, \<1 year post-partum, breast-feeding and/or pregnant.
- 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.
Where
- Fort Collins, Colorado
Collaborators
University of Colorado, Denver, Salk Institute for Biological Studies, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations