RECRUITING

Countermeasures to Circadian Misalignment

Conditions

Circadian Rhythm Sleep Disorder of Shift Work Type Metabolic Disease Insulin Sensitivity Shift work Sleep Blood sugar Metabolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Time-restricted Feeding to Mitigate Metabolic Impairments During Circadian Misalignment

Quick Facts

Study Start:2021-07-07

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04966351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Josiane L Broussard, PhD

CONTACT

9704913103

josiane.broussard@colostate.edu

Ellen Lyon, MS

CONTACT

9704913103

ellen.lyon@colostate.edu

Study Locations (Sites)

Colorado State University

Fort Collins, Colorado, 80523

United States

Collaborators and Investigators

Sponsor: Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-07

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-07-07

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Shift work
Sleep
Blood sugar
Metabolism

Additional Relevant MeSH Terms

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