Circadian Rhythm Sleep Disorder of Shift Work TypeC2CMNCT04966351
Countermeasures to Circadian Misalignment
A study testing Time-restricted feeding and Circadian Misalignment in people with Circadian Rhythm Sleep Disorder of Shift Work Type and Metabolic Disease, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease, Insulin Sensitivity
- What is being tested?
- Time-restricted feeding and Circadian Misalignment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to 30 Jun 2026
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Ellen Lyon, M.S., 970-491-3103, sleep-study@colostate.edu
About this study
Official title: Time-restricted Feeding to Mitigate Metabolic Impairments During Circadian Misalignment
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.
Read the detailed description
People who work evening, night or rotating shifts (i.e. "nonstandard" work hours) represent one in five U.S. employees and are alarmingly 44% more likely to develop Type 2 diabetes (T2D) compared to people who work standard day shifts. Circadian misalignment is one mechanism suggested to increases the risk of obesity and diabetes in people who work non-standard hours, and is highly prevalent and often unavoidable in modern, 24-hour society (e.g. shift work, long work hours, jet lag, medical residency, emergency responders, military personnel, Daylight Savings Time changes, etc). Disruptions in sleep and circadian rhythms have been linked to insulin resistance, increased energy intake, weight gain, and increased total body, abdominal and intrahepatic fat content, yet there have been limited attempts at identifying strategies or countermeasures to prevent the impact of such disruption on T2D risk in a sizeable proportion of the population.
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
- Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease, Insulin Sensitivity
- Being tested
- Time-restricted feeding, Circadian Misalignment
- Keywords
- Shift work, Sleep, Blood sugar, Metabolism
- Medical subject headings
- Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted feedingBehavioural
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 MisalignmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Circadian misalignment (Condition A) | Experimental | Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts. Receives: Behavioral: Circadian Misalignment |
| Circadian misalignment with time-restricted feeding (Condition B) | Experimental | Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts. Receives: Behavioral: Time-restricted feeding; Behavioral: Circadian Misalignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity-derived from glucose tolerance test
Measured: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
Muscle tissue lipids-assessed by lipidomic analyses
Measured: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
Secondary outcomes (3)
24-hour circulating blood glucose levels-assessed by assay
Measured: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
24-hour circulating blood insulin levels-assessed by assay
Measured: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
24-hour circulating blood free fatty acid levels-assessed by assay
Measured: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start7 Jul 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm Sleep Disorder of Shift Work TypeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Salk Institute for Biological Studies, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966351
- Sponsor's protocol ID
- 19-9666H
- Other IDs
- R01DK125653
- Acronym
- C2CM
- Status last verified
- Jul 2025
- First submitted
- 9 May 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Feeding to Mitigate Metabolic Impairments During Circadian Misalignment
- ClinicalTrials.gov ID
- NCT04966351
- Acronym / sponsor ID
- C2CM / 19-9666H
- Conditions
- Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease, Insulin Sensitivity
- Keywords
- Shift work, Sleep, Blood sugar, Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Salk Institute for Biological Studies, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Jul 2021 (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.
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.
Detailed description
People who work evening, night or rotating shifts (i.e. "nonstandard" work hours) represent one in five U.S. employees and are alarmingly 44% more likely to develop Type 2 diabetes (T2D) compared to people who work standard day shifts. Circadian misalignment is one mechanism suggested to increases the risk of obesity and diabetes in people who work non-standard hours, and is highly prevalent and often unavoidable in modern, 24-hour society (e.g. shift work, long work hours, jet lag, medical residency, emergency responders, military personnel, Daylight Savings Time changes, etc). Disruptions in sleep and circadian rhythms have been linked to insulin resistance, increased energy intake, weight gain, and increased total body, abdominal and intrahepatic fat content, yet there have been limited attempts at identifying strategies or countermeasures to prevent the impact of such disruption on T2D risk in a sizeable proportion of the population.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadian misalignment (Condition A) | Experimental | Behavioral: Circadian MisalignmentParticipants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts. |
| Circadian misalignment with time-restricted feeding (Condition B) | Experimental | Behavioral: Time-restricted feeding, Behavioral: Circadian MisalignmentParticipants will fast during the biological nighttime while remaining awake to mimic overnight work shifts. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Time-restricted feedingEach 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. | Behavioural | Circadian misalignment with time-restricted feeding (Condition B) |
| Circadian MisalignmentHealthy 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. | Behavioural | Circadian misalignment (Condition A), Circadian misalignment with time-restricted feeding (Condition B) |
Primary outcome
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.
3 secondary outcomes
24-hour circulating blood glucose levels-assessed by assay
Time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
24-hour circulating blood insulin levels-assessed by assay
Time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
24-hour circulating blood free fatty acid levels-assessed by assay
Time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
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 24 Jul 2025.
- Josiane Broussard's BibliographyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted feeding and Circadian Misalignment in people with Circadian Rhythm Sleep Disorder of Shift Work Type and Metabolic Disease, run by Colorado State University 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 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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 Josiane L Broussard, PhD (9704913103, josiane.broussard@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity-derived from glucose tolerance test (time frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33.). The study lists 2 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 24 Jul 2025.