Recruiting

Metabolic Homeostasis

Sponsor:

Colorado State University

Code:

NCT04966351

Conditions

Circadian Rhythm Sleep Disorder of Shift Work Type

Metabolic Disease

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Time-restricted feeding

Circadian Misalignment

Study Details

Brief 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.

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.

Conditions

Circadian Rhythm Sleep Disorder of Shift Work Type

Metabolic Disease

Insulin Sensitivity

Study ID

NCT04966351

Start date

Jul 7, 2021

Status verified date

Jul, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18-35 old; men and women; equal numbers of women and men will be included.
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:

1. Any clinically significant medical, psychiatric, or sleep disorder
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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Circadian misalignment (Condition A)

Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts.

experimental: Circadian misalignment with time-restricted feeding (Condition B)

Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts.

Interventions

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.

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. ]
  • Muscle tissue lipids-assessed by lipidomic analyses [ Time Frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33. ]

Central Contacts and Locations

Central contacts

Josiane L Broussard, PhD

9704913103josiane.broussard@colostate.edu

Ellen Lyon, MS

9704913103ellen.lyon@colostate.edu

Locations

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Ellen Lyon, M.S.

970-491-3103sleep-study@colostate.edu

More Information

Sponsor

Colorado State University

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • Shift work
  • Sleep
  • Blood sugar
  • Metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2025-07-24.