Countermeasures to Circadian Misalignment

NCT04966351 | Recruiting DMC

• 2 other identifiers: 19-9666HR01DK125653
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Shift work; Sleep; Blood sugar; Metabolism

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity-derived from glucose tolerance test

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

• Muscle tissue lipids-assessed by lipidomic analyses

  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

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

• 24-hour circulating blood insulin levels-assessed by assay

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

• 24-hour circulating blood free fatty acid levels-assessed by assay

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

Other Outcomes (11)

• Cognitive assessments-Karolinska Sleepiness Scale

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

• Cognitive assessments-Positive and Negative Affect Schedule

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

• Cognitive assessments- Psychomotor Vigilance Task

  Change to be assessed at Day 3, Day 5, Day 31, Day 33.

Study Arms (2)

Circadian misalignment (Condition A)

EXPERIMENTAL

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

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.

Behavioral: Time-restricted feeding; Behavioral: Circadian Misalignment

Interventions

Time-restricted feeding BEHAVIORAL

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 with time-restricted feeding (Condition B)

Circadian Misalignment BEHAVIORAL

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 (Condition A); Circadian misalignment with time-restricted feeding (Condition B)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• University of Colorado, Denver: collaborator
• Salk Institute for Biological Studies: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

Related Links

• Josiane Broussard's Bibliography

MeSH Terms

Conditions

Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Central Study Contacts

Josiane L Broussard, PhD

CONTACT

9704913103; josiane.broussard@colostate.edu

Ellen Lyon, MS

CONTACT

9704913103; ellen.lyon@colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: July 19, 2021
• Study Start: July 7, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)