Countermeasures to Circadian Misalignment

ConditionsCircadian Rhythm Sleep Disorder of Shift Work Type Metabolic Disease Insulin Sensitivity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-35

SponsorColorado State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

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
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.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Circadian misalignment (Condition A)Experimental treatment 1 intervention

Group B: Circadian misalignment with time-restricted feeding (Condition B)Experimental treatment 2 interventions